Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

开始日期2025-05-01

申办/合作机构

中国医科大学

NCT06914687

/ Not yet recruiting临床2期IIT

Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)

For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma.

开始日期2025-03-30

申办/合作机构

复旦大学

NCT06808971

/ Recruiting临床2期IIT

A Phase II Clinical Trial of Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur Gimeracil Oteracil Potassium Capsule for Perioperative Treatment of Locally Advanced Resectable Gastric/Gastroesophageal Adenocarcinoma

This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.
After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).
Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.

开始日期2025-02-05

申办/合作机构

中国医学科学院肿瘤医院

100 项与替吉奥相关的临床结果

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100 项与替吉奥相关的转化医学

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100 项与替吉奥相关的专利（医药）

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6,310

项与替吉奥相关的文献（医药）

2025-09-01·EJSO

Investigation of neoadjuvant gemcitabine plus cisplatin-based triplet regimens on biliary tract cancer with possible lymph node metastasis

Article

作者: Takahashi, Hidenori ; Doki, Yuichiro ; Noda, Takehiro ; Eguchi, Hidetoshi ; Hasegawa, Shinichiro ; Tomimaru, Yoshito ; Akita, Hirofumi ; Sasaki, Kazuki ; Kobayashi, Shogo ; Yamada, Daisaku

INTRODUCTION:

Biliary tract cancer (BTC) is rare. The treatment outcomes in patients with lymph node (LN) metastasis diagnosed by FDG-PET or a biopsy-who are considered to be 'biologically borderline resectable'-are poor. However, perioperative treatment is still under development. Recently, gemcitabine plus cisplatin (GC)-based triplet regimens for unresectable BTC have been developed. We applied GC-based triplet therapy in BTC with LN metastasis.

METHODS:

We administered GC plus S-1 therapy (GCS) or nab-paclitaxel therapy (GCnP) to 30 patients with LN metastasis diagnosed by FDG-PET or a biopsy (GC-based triplet group). A dataset of BTC with FDG-positive LNs, previously used for an analysis of the diagnosis and treatment outcomes according to FDG uptake, was used as a control (upfront surgery group, n = 19).

RESULTS:

GCS and GCnP were used by 22 and 8 patients, respectively. The median treatment period was 79 days, the objective response rate was 47 %, the tumor control rate was 87 %, and 22 patients underwent R0 resection (73 %). The groups showed no significant differences with the exception of the FDG uptake by the main tumor. The three-year overall survival (OS) rates in the GC-based triplet and upfront surgery groups were 45.4 % and 15.8 %, respectively (P = 0.0052); there were no significant differences in progression-free or recurrence-free survival. A sub-analysis showed that normalized CA19-9 levels provided better survival than non-normalized CA19-9 levels.

CONCLUSION:

Neoadjuvant GC-based triplet regimens could provide survival benefits in BTC with LN metastasis diagnosed by FGD-PET or a biopsy. CA19-9 normalization may be useful for indicating surgery.

2025-07-01·SEPARATION AND PURIFICATION TECHNOLOGY

Functional ionic liquid anchored TS-1 molecular sieve with multiple adsorption sites for efficient capture and separation of CO2 in flue gas systems

作者: Yuan, Maojie ; Liu, Yanduo ; Tang, Xuqi ; Guo, Xin ; An, Yongqi ; Hu, Yufeng ; Meng, Zitao ; Jiao, Jianhao ; Wang, Bingcan ; Qin, Yucai ; Li, Qiang ; Liu, Qinghua

Solid adsorption using porous mol. sieves are promising technol. to capture CO₂ from the air and industrial gases.However, the adsorption capacity and stability for most mol. sieves in complex gas systems are undesirable.The presence of alk. substances can improve the absorption capacity of materials by altering the surface properties and enhancing the interaction with CO₂.To improve the adsorption performance, we introduced amine functionalized ionic liquids (ILs) 1-aminopropyl-3-methylimidazolium bromide (APMImBr, with one amine group) and Bis-(3-aminopropyl-1-imidazole) ethylidene dibromide (BAPImEDB, with two amine group) on the surface of TS-1 mol. sieve.Under optimal exptl. conditions, APMImBr and BAPImEDB modified TS-1 mol. sieves have high adsorption capacity (increased by 148.5% and 218%, resp.) and universal adaptability and renewability.According to CO₂-TPD, XPS spectrum and quantum chem. calculations, the role of amine-based ILs can significantly enhance the weak and medium-strength basic sites, forming a multi-point alk. effect and enhancing the adsorption capacity through weak interactions (van der waals and hydrogen bonding) with CO₂.Overall, the research on multi amine functionalized ionic liquid composite solid adsorbents based on porous mol. sieves for carbon dioxide capture and recovery provides valuable insights for achieving sustainable development goals.

2025-07-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Chronopharmacokinetic model analysis of 5-fluorouracil following S-1 administration in rats: comparison with infusion and other prodrugs for chronochemotherapy

Article

作者: Kobuchi, Shinji ; Satake, Tomoki ; Ito, Yukako

Circadian rhythms influence the pharmacokinetics of chemotherapeutic agents, including 5-fluorouracil, a cornerstone drug for colorectal cancer treatment. While chronomodulated chemotherapy for 5-fluorouracil infusion regimens can improve patient outcomes, the impact of circadian rhythms on oral 5-fluorouracil prodrug regimens remains poorly understood, and no dose-timing strategies have been established. This study investigated circadian variations in the pharmacokinetics of 5-fluorouracil after administering S-1, an oral fluoropyrimidine-based anticancer drug, in rats using a cosinor-based chronopharmacokinetic model. Plasma tegafur exposure showed significant circadian variation, peaking at 01:00 (17 h after light onset), whereas plasma 5-fluorouracil exposure exhibited no significant time-of-dosing differences. Chronopharmacokinetic analysis revealed minimal circadian variation in 5-fluorouracil clearance with S-1 (amplitude-to-mesor ratio: ±14.6 %) compared to long-term 5-fluorouracil infusion (±28.0 %) and other oral prodrugs including capecitabine (±43.0 %) and uracil-tegafur (±36.7 %), which showed pronounced fluctuations. These results suggest that S-1 provides consistent 5-fluorouracil exposure regardless of dosing time, offering a practical advantage by simplifying treatment schedules and reducing the need for chronomodulated therapy. This study could advance the development of 5-fluorouracil-based chronochemotherapy using oral prodrug regimens, enabling more personalized and effective cancer treatment strategies.

105

项与替吉奥相关的新闻（医药）

2025-05-30

·深圳微芯生物科技股份有限公司

直击ASCO 2025丨完全缓解率超95%！西达本胺口头报告联合方案初治NK/T细胞淋巴瘤优异数据

ASCO 2025年会首日，中山大学附属肿瘤医院黄慧强教授口头报告了西达本胺联合PD-1治疗初治NK/T细胞淋巴瘤的最新成果（SCENT研究2.0）。研究亮点如下：Sintilimab (anti-PD-1 antibody) combined with chidamide (an oral subtype-selective HDACi) followed by P-GemOx regimen in patients with treatment-naive extranodal natural killer/T cell lymphoma (TN-ENKTL): A multicenter, open-label, single-arm, phase II study (SCENT-2 trial)中文：信迪利单抗（抗PD-1抗体）联合西达本胺（一种口服亚型选择性组蛋白去乙酰化酶抑制剂，HDACi），随后采用培门冬酶-吉西他滨-奥沙利铂（P-GemOx）方案治疗初治结外自然杀伤/T细胞淋巴瘤（treatment-naive extranodal natural killer/T cell lymphoma, TN-ENKTL）患者：一项多中心、开放标签、单臂、Ⅱ期临床研究（SCENT-2试验）摘要编号：7006会议环节Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia（血液系统恶性肿瘤——淋巴瘤与慢性淋巴细胞白血病）展示时间5月30日 2:45PM-5:45PM（美国中部时间）5月31日 3:45AM-6:45AM（北京时间）主要作者黄慧强，中山大学肿瘤防治中心核心要点ENKTL是一种高度侵袭性的非霍奇金淋巴瘤，在亚洲发病率较高。P-GemOx 方案是标准的一线治疗方案。SCENT1.0已证实，西达本胺联合信迪利单抗（SC）方案对复发或难治性ENKTL 患者安全有效。对于初治患者，使用SC方案可能进一步优化预后。SCENT研究2.0为一项前瞻性研究，目的是评估SC联合P-GemOx治疗初治ENKTL的疗效和安全性。2022 年 8 月至 2024 年 12 月期间，研究共入组 47 例符合条件的患者。患者首先接受2个周期的标准剂量SC方案治疗（A部分）。一旦患者达到完全缓解（CR）或部分缓解（PR），则接受2个周期的P-GemOx方案治疗（B部分）。完成 2 个周期 SC 方案治疗的 46 例可评估疗效患者中，78.2%获得缓解，60.3%达到完全缓解；B 部分治疗后，42 例可评估疗效患者中，完全缓解率高达 95.2%，客观缓解率达 97.6%；1 年疾病控制率、无进展生存率和总生存期率分别为 96.2%、97.5%和 95.3%。不良事件：中性粒细胞减少（97.8%）、淋巴细胞减少（89.4%）、贫血（74.5%）、血小板减少（58.7%），非血液不良事件包括食欲不振（38.3%）、恶心（38.3%）、脂肪酶升高（31.9%）。大多数毒性反应来自 P-GemOx。SCENT-2试验的初步结果超出预期疗效。对于这一人群，它可能是一种有前景的化疗减少治疗和可控毒性的方法,待要进一步研究。此前，黄教授牵头的SCENT1.0研究在复发/难治NK/T细胞淋巴瘤治疗领域成果显著，西达本胺联合PD-1方案将晚期复发患者中位生存期从6个月大幅延长至32.9个月，数据翻5倍，治愈率提升至48.6%。SCENT研究2.0聚焦初治患者，结果显示西达本胺能显著改善肿瘤微环境、克服免疫耐药，治疗方案在临床中得以验证。本届ASCO年会，西达本胺用于治疗晚期尿路上皮癌、软组织肉瘤、胆道癌、胰腺癌、乳腺癌等领域成果相继展示：壁报1Final results of a phase II study of HDACi chidamide and PD-1 inhibitor for advanced urothelial carcinoma after platinum therapy中文：西达本胺（HDACi）联合PD-1单抗治疗含铂方案治疗失败的晚期尿路上皮癌的Ⅱ期临床研究最终结果摘要编号：4563展示时间6月2日 9:00AM-12:00PM （美国中部时间）6月3日 10:00AM-1:00PM（北京时间）主要作者刘卓炜中山大学肿瘤防治中心核心要点表观遗传失调与尿路上皮癌的发病机制及进展密切相关。前期研究显示，西达本胺联合替雷利珠单抗在晚期或转移性尿路上皮癌（mUC）患者中耐受性良好且展现出临床意义的抗肿瘤活性，确认的客观缓解率（ORR）为41.7%，中位无进展生存期（PFS）为4.6个月。本文报告最终分析结果。2021年1月至2023年10月期间，中山大学肿瘤防治中心共入组45例患者。截至数据截止日期（2024年8月），中位随访时间为23.2个月（95% CI: 17.2-31.9）。患者中位年龄63岁（IQR: 57-68）。确认的ORR为44.4%（12例完全缓解，8例部分缓解；95% CI: 29.6-60.0%），DCR为60%（27/45；95% CI: 44.3-74.3%）。缓解持续时间（DOR）尚未获得（95% CI: 8.8-NE）。中位PFS为7.0个月（95% CI: 2.4-10.3），中位OS为20.3个月（95% CI: 10.7-NE）。治疗相关不良事件（TEAE）以贫血、食欲减退、血小板减少、中性粒细胞减少、白细胞减少、疲劳和低蛋白血症最常见。≥3级TEAE（发生率≥10%）包括中性粒细胞减少（24.4%）、血小板减少（20.0%）和贫血（13.3%）。无治疗相关死亡事件。研究首次证实HDAC抑制剂联合PD-1单抗在mUC中具有可行性和显著疗效。西达本胺联合替雷利珠单抗可为该患者群体提供新的治疗选择。壁报2A phase II, multicenter trial of the combination of chidamide and toripalimab in patients with advanced soft tissue sarcoma: Efficacy updates中文：西达本胺联合特瑞普利单抗治疗晚期软组织肉瘤患者的Ⅱ期多中心临床试验：疗效最新进展摘要编号：11560展示时间5月31日 9:00AM-12:00PM （美国中部时间）6月1日 10:00AM-1:00PM（北京时间）主要作者张星中山大学肿瘤防治中心核心要点西达本胺是一种口服亚型选择性组蛋白去乙酰化酶抑制剂，对血液系统肿瘤患者有效，据报道可增强免疫检查点阻断疗法的疗效并调节宿主免疫反应。既往研究团队报告了西达本胺联合特瑞普利单抗治疗软组织肉瘤患者的初步研究结果。此次最新研究成果提示，西达本胺联合特瑞普利单抗每21天给药方案耐受性良好，在晚期软组织肉瘤患者中显示出良好的抗肿瘤活性。截至数据截止日期（2025年1月），共纳入69例晚期软组织肉瘤患者。患者中位年龄47岁（范围16-68岁），中位既往治疗线数为2（范围0-5）。主要亚型包括平滑肌肉瘤（29%）、高分化/去分化脂肪肉瘤（36.2%）、未分化肉瘤（7.2%）、黏液样/圆细胞脂肪肉瘤（4.3%）和骨肉瘤（4.3%）。在69例疗效可评估患者中，总缓解率（ORR）和疾病控制率（DCR）分别为29%和73.9%。中位至首次缓解时间为5个月（95%CI 3-7），中位无进展生存期（mPFS）为7.1个月（95%CI 4.0-10.2），中位总生存期（OS）尚未达到。治疗耐受性良好，最常见不良事件为1-2级，包括贫血（55.1%）、甲状腺功能减退（44.9%）、白细胞减少（33.3%）、血小板减少（30.4%）、中性粒细胞减少（24.6%）、恶心/呕吐（24.6%）和疲劳（15.9%）。3-4级不良事件中最常见为中性粒细胞减少（27.5%）、血小板减少（23.2%）、白细胞减少（14.5%）、恶心/呕吐（10.1%）和贫血（1.4%）。在线摘要1Dalpiciclib combined with chidamide and letrozole as neoadjuvant therapy for HR-positive，HER2-negative early or locally advanced breast cancer: A single-arm, prospective, exploratory clinical study中文：达尔西利联合西达本胺和来曲唑作为激素受体阳性、人表皮生长因子受体2阴性早期或局部晚期乳腺癌的新辅助治疗：一项单臂、前瞻性、探索性临床研究摘要编号：e12593主要作者史源安阳市肿瘤医院核心要点激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）乳腺癌（BC）对新辅助治疗的病理完全缓解率（pCR）和客观缓解率（ORR）较低，亟需探索更有效的治疗方案。达尔西利是一种新型CDK4/6抑制剂，西达本胺为口服选择性组蛋白去乙酰化酶抑制剂。本研究旨在评估达尔西利联合西达本胺和来曲唑作为HR+/HER2-乳腺癌新辅助治疗的疗效与安全性。本研究共纳入23例患者，所有患者ER表达均≥50%，74%（17/23）的患者Ki67表达≥20%。其中完成新辅助治疗并接受手术的12例患者，残留癌症负荷（RCB）0/Ⅰ率为25%（95% CI, 5.5%-49.5%），总病理完全缓解率（tpCR）为25%（95% CI, 5.5%-49.5%），总缓解率（ORR）为92%（95% CI, 61.5%-100.0%）；完成两个治疗周期并进行疗效评估的共20例患者，总缓解率（ORR）为75%（95% CI, 50.9%-94.0%）。最常见不良事件为中性粒细胞减少（100%）、白细胞计数减少（86%）。3级及以上不良事件包括中性粒细胞减少（82%）、白细胞计数减少（55%）。其他大多数AEs主要为1-2级。研究显示，达尔西利+西达本胺+来曲唑的三联方案在 HR+/HER2-乳腺癌中展现出一定潜力，待更大规模研究验证其长期获益。在线摘要2Dalpiciclib plus chidamide in HR+/HER2- advanced breast cancer following CDK4/6 inhibitor treatment failure: Final results of a phase Ib trial中文：达尔西利（Dalpiciclib）联合西达本胺（Chidamide）用于激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）晚期乳腺癌CDK4/6抑制剂治疗失败后的研究：一项Ib期临床试验的最终结果摘要编号：e13071主要作者王涛解放军总医院第五医学中心核心要点本研究为单臂Ib期剂量递增试验，采用贝叶斯最优区间设计探索CDK4/6i治疗失败的HR+/HER2-晚期乳腺癌患者中达尔西利联合西达本胺的疗效与安全性。共入组22例CDK4/6抑制剂经治HR+/HER2-局部复发或转移性乳腺癌患者，入组患者既往在复发或转移性疾病阶段接受过≤1线化疗，患者被分配到4组接受西达本胺（A组：达尔西利125 mg/日和西达本胺25 mg/BIW；B组：达尔西利125 mg/日和西达本胺20 mg/BIW；C组：达尔西利100 mg/日和西达本胺 25 mg/BIW；D组：达尔西利100 mg/日和西达本胺20 mg/BIW）。主要终点为最大耐受剂量（MTD）。观察到3例剂量限制性毒性，均为4级血小板减少。总体患者ORR 为9.1%（C组16.7%），总体中位PFS 5.8个月（C组达12.3个月）；二代测序（NGS）显示14例患者中8例（57%）存在PIK3CA突变，4例（29%）ESR1突变，4例（29%）TP53突变。野生型患者较突变型患者显示出更优的PFS趋势。确定C组（100mg/d+25mg BIW）为MTD；3-4级不良事件以中性粒细胞减少（100%）、白细胞减少（64%）和血小板减少（32%）为主。该联合方案可作为CDK4/6i治疗失败后HR+/HER2- BC患者的替代治疗策略。在线摘要3Envafolimab and chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (Benefits/ScOG-B001):A single-arm, exploratory, phase II trial中文：恩沃利单抗（Envafolimab）和西达本胺（Chidamide）联合吉西他滨+奥沙利铂（GEMOX）方案作为晚期和转移性胆道癌的一线治疗（Benefits/ScOG-B001研究）：一项单臂、探索性II期临床试验摘要编号：e16231主要作者李伟苏州大学附属第一医院核心要点胆道癌（BTC）是一类恶性程度高、预后差的罕见肿瘤。恩沃利单抗是一种轻链缺失型PD-L1单抗，西达本胺为亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂。本研究通过单臂、多中心、前瞻性Ⅱ期临床试验（ChiCTR2400080783），评估恩沃利单抗联合西达本胺与GEMOX方案一线治疗晚期BTC的疗效与安全性。在这项研究中，恩沃利单抗联合西达本胺与GEMOX方案一线治疗晚期BTC表现出显著的短期疗效，客观缓解率（ORR）达到51.43%（18/35），疾病控制率（DCR）为77.14%(27/35)，中位无进展生存期（PFS）达到8.13个月，相较于传统GEMOX单药治疗（中位PFS约6个月）显示出更优的生存获益趋势，总生存期（OS）数据尚未完全成熟。安全性特征显示所有患者均出现治疗相关不良事件（TRAEs，100%），其中68.57%（24/35例）为3级及以上的毒性反应，主要集中于血液学毒性：血小板减少（48.57%）、贫血（37.14%）和白细胞减少（37.14%）。非血液学毒性以1-2级消化道反应（如恶心、腹泻）和乏力为主，整体耐受性可控。该研究首次验证PD-L1抑制剂联合表观遗传药物与化疗在晚期BTC中的协同价值，为BTC患者提供新选择。在线摘要4Efficacy of adebrelimab with chidamide, gemcitabine, and S-1 in locally advanced or metastatic pancreatic cancer: A phase II study中文：阿得贝利单抗（Adebrelimab）联合西达本胺（Chidamide）、吉西他滨和替吉奥（S-1）治疗局部晚期或转移性胰腺癌的疗效：一项II期研究摘要编号：e16365主要作者刘秀峰东部战区总医院；李剑萍盐城市第一人民医院核心要点西达本胺为亚型选择性HDAC抑制剂，与化疗、免疫及内分泌治疗存在协同增效机制，并在多瘤种中显示出临床有效性。截至2024年12月27日，13例局部晚期/转移性胰腺癌患者接受阿得贝利单抗、西达本胺、吉西他滨和替吉奥一线治疗。客观缓解率（ORR）为62%，疾病控制率（DCR）为92%；中位至缓解时间（TTR）为1.66个月,中位无进展生存期（PFS）为9.0个月，总生存期（OS）为14.2个月。CA199水平下降≥40%的患者均实现客观缓解。≥3级治疗相关不良事件包括白细胞降低（23%）、血小板降低（15%），所有不良事件经对症处理后缓解，无患者因不良反应停药。结果显示西达本胺联合治疗可显著增强免疫治疗及化疗疗效，较单纯化疗或化疗联合免疫方案更具优势，并具有良好耐受性。关于西达本胺（商品名：爱谱沙®）西达本胺（Chidamide；商品名：爱谱沙®/Epidaza®）是全球首个亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂、中国首个原创抗肿瘤化学新药、国家1类新药。西达本胺对肿瘤抑制性免疫微环境具有重新激活作用，可单独或联合其他药物治疗恶性肿瘤，具有广阔的应用前景。西达本胺在中国已获批外周T细胞淋巴瘤、乳腺癌、弥漫大B细胞淋巴瘤3个适应症；在日本获批成人T细胞白血病和外周T细胞淋巴瘤2个适应症；在中国台湾获批乳腺癌适应症；联合不同肿瘤免疫疗法的多项临床试验研究正在中国及国际范围推进中。往期推荐瘦不下来？可能是胰岛素抵抗！不管胖哪里，都不要胖这里！微芯生物倡导高质量体重管理

临床结果ASCO会议临床2期

2025-05-23

·和黄医药官微

和黄医药将于美国临床肿瘤学会(ASCO)2025年年会公布数据

中国香港、上海和美国新泽西州：2025年5月23日，星期四：和黄医药(中国)有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布和黄医药自主研发的化合物赛沃替尼、HMPL-306 (ranosidenib)、呋喹替尼和索凡替尼的数项研究的最新及更新后的数据将于2025年5月30日至6月3日在美国芝加哥召开的2025年美国临床肿瘤学会(ASCO) 年会上公布。SACHI中国III期研究的结果将以最新突破性口头报告的形式公布，该研究旨在评估赛沃替尼联合奥希替尼用于一线表皮生长因子受体 ("EGFR") 抑制剂治疗后疾病进展的EGFR突变阳性伴MET扩增的局部晚期或转移性非小细胞肺癌患者。 SACHI 在预设的中期分析中已达到预设的主要终点无进展生存期 ("PFS")。SACHI研究的数据支持了该口服疗法的新药上市申请，该申请已于中国获受理并纳入优先审评。赛沃替尼联合奥希替尼用于治疗既往接受奥希替尼治疗后疾病进展、伴有MET过表达和/或扩增的EGFR突变的非小细胞肺癌患者的SAVANNAH II期研究中高MET过表达和/或扩增亚组的进一步数据，以及根据脑转移状态分层的分析结果亦于大会公布。与赛沃替尼加安慰剂相比，赛沃替尼和奥希替尼的联合疗法显示出更佳的疗效。此联合疗法显示出良好的中枢神经系统活性，延缓中枢神经系统进展并减少新的中枢神经系统病灶。HMPL-306的I期临床试验剂量递增阶段的结果将于大会公布。HMPL-306是一种新型、高选择性的小分子口服异柠檬酸脱氢酶 ("IDH")1和IDH2酶双重抑制剂，正于伴有IDH突变的局部晚期或转移性实体瘤患者中开展研究。结果显示，该药物耐受性良好，在患者中显示出靶点抑制和持久的缓解。研究观察到疗效信号，且在低级别胶质瘤的疗效评估组 (N=14)中尤其显著，客观缓解率 ("ORR")为7.1%，疾病控制率 ("DCR")为100%。FRUSICA-1 开放标签、单臂、关键性II期临床试验的亚组分析结果亦将公布，该研究旨在评估呋喹替尼联合信迪利单抗用于治疗经治的晚期错配修复完整 (pMMR) 子宫内膜癌患者的疗效和安全性。浆液性癌患者 (N=27) 中观察到具有临床意义的疗效结果，与整体研究人群 (N=98) 中观察到的缓解情况相似。独立审查委员会 ("IRC") 评估的ORR为37.0%，DCR为88.9%。在缓解是否会受到既往新辅助/辅助化疗 ("NACT/ACT") 影响的分析中表明，无论患者既往是否曾接受 NACT/ACT治疗，均显示出持久且具有临床意义的缓解。接受过和未接受NACT/ACT治疗的患者的结果相若，IRC 评估的ORR分别为34.0%和31.4%，DCR分别为85.1%和82.4%。两项来自呋喹替尼在中国2798名结直肠癌患者中开展的IV期研究的亚组分析结果将会公布。在评估呋喹替尼单药疗法和联合疗法安全性的亚组分析中，呋喹替尼在两组中均显示出可控的安全性。3级以上治疗期间不良事件 (TEAE) 在呋喹替尼单药治疗组中发生率为23.94%，与其他抗癌药物联合疗法组则为26.06%。两组中最常见的治疗相关不良事件 (TRAE) 均为掌跖红肿感觉异常 (PPES) 和高血压。联合疗法组的治疗持续时间更长，这可能表明患者的治疗结果有所改善。在按年龄分组的亚组分析中，评估了呋喹替尼在较年轻患者 (年龄<50岁) 和高龄患者 (年龄≥75岁) 中的安全性。两个年龄组中的安全性相似，较年轻患者接受了更为密集的治疗。呋喹替尼联合疗法的治疗持续时间在两个年龄组中也均优于单药疗法，这可能表明带来更高的生存获益。报告详情包括已公布的摘要链接如下：公司申办的研究标题：赛沃替尼联合奥希替尼对比化疗用于治疗EGFR TKI治疗后疾病进展的EGFR突变伴MET扩增的晚期非小细胞肺癌：SACHI III期随机研究的结果Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study主要作者：陆舜，上海交通大学医学院附属胸科医院上海肺癌中心，中国上海会议环节：口头报告 | Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：LBA8505时间：2025年6月1日 (星期日) 北美中部夏令时上午9:48标题：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的SAVANNAH II期研究中随机亚组的疗效和中枢神经系统结果Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) 主要作者：Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 会议环节：快速口头报告 | Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：8513时间：2025年6月2日 (星期一) 北美中部夏令时上午8:06标题：IDH1/IDH2突变抑制剂HMPL-306用于治疗晚期IDH突变的实体瘤 (包括神经胶质瘤) 西方患者的I期研究Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma主要作者：Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX会议环节：快速口头报告 | Rapid Oral Session: Central Nervous System Tumors摘要编号：2013时间：2025年5月31日 (星期六) 北美中部夏令时下午3:06标题：FRUSICA-1研究中浆液性癌的亚组分析: 呋喹替尼联合信迪利单抗用于治疗晚期pMMR子宫内膜癌患者Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status主要作者：吴小华，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5596 标题：既往新辅助/辅助化疗 (NACT/ACT) 对呋喹替尼联合信迪利单抗在晚期pMMR子宫内膜癌患者中治疗结果的影响: FRUSICA-1研究的亚组分析The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1主要作者：王静，湖南省肿瘤医院，中国长沙会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5611标题：真实世界临床实践中呋喹替尼治疗年轻和高龄结直肠癌中国患者的安全性: 呋喹替尼IV期研究的年龄亚组分析Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study主要作者：王奕，宁波市第二医院，中国宁波会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15512标题：真实世界临床实践中呋喹替尼单药疗法和联合疗法治疗中国结直肠癌患者的安全性: IV期研究的亚组分析Safety of fruquintinib monotherapy and combination therapy in Chinese patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study主要作者：王志强，中山大学肿瘤防治中心，中国广州会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15515标题：血管生成抑制剂和化疗用于晚期胃腺癌或胃食管结合部腺癌患者的适当治疗顺序: FRUTIGA III期研究的探索性分析The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study主要作者：李进，同济大学附属东方医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16011标题：FRUTIGA研究中呋喹替尼联合紫杉醇对比紫杉醇用于治疗胃食管结合部腺癌的疗效和安全性亚组分析: 一项二线治疗胃/胃食管结合部腺癌的随机III期临床试验Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/ gastroesophageal junction 主要作者：刘天舒，复旦大学附属中山医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16012研究者发起的研究标题：呋喹替尼联合卡瑞利珠单抗和紫杉醇脂质体和奈达铂用于一线治疗晚期食道鳞状细胞癌: 一项单臂II期研究Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study 主要作者：顾艳宏，江苏省人民医院 (南京医科大学第一附属医院)，中国南京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4042标题：呋喹替尼联合PD-1抑制剂及化疗用于一线治疗HER2阴性的晚期胃癌或胃食管结合部腺癌(FDZL-FIX)的更新结果: 一项单臂、开放标签II期研究Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study主要作者：王辰辰，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4046标题：呋喹替尼联合曲妥珠单抗及XELOX方案用于一线治疗晚期HER2阳性的转移性胃腺癌或胃食管结合部腺癌的开放标签、单臂、单中心Ib/II期临床试验Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma主要作者：吕慧芳，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：TPS4203标题：转移性结直肠癌治疗的多队列真实世界研究: 整体疗效分析以及既往是否使用贝伐珠单抗的亚组分析A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not 主要作者：吕汪霞，浙江省肿瘤医院，中国杭州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15530标题：呋喹替尼联合伊立替康和卡培他滨用于二线治疗晚期结直肠癌的真实世界观察性研究Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer主要作者：徐玲，中国医科大学附属第一医院，中国沈阳会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15539 标题：呋喹替尼联合FOLFIRI方案用于二线治疗RAS突变的转移性结直肠癌的初步结果: 一项前瞻性单中心II期研究 Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study主要作者：贾茹，解放军总医院第五医学中心，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15541标题：评估呋喹替尼对比瑞戈非尼和曲氟尿苷/替吡嘧啶用于治疗晚期转移性结直肠癌的疗效: 匹配调整间接比较Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/ tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison主要作者：秦叔逵，中国药科大学附属南京天印山医院，中国南京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15550标题：呋喹替尼联合信迪利单抗和SOX方案作为初始不可切除的胃/胃食管结合部腺癌的转化治疗: 单臂II期临床试验的更新疗效和手术结果Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial主要作者：马飞，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16016标题：一项评估呋喹替尼联合恩沃利单抗用于治疗晚期或不可切除的局部晚期骨肉瘤和软组织肉瘤患者的疗效和安全性的II期研究A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma主要作者：周陈亮，上海交通大学附属第六人民医院，中国上海会议环节：线上发表 | Publication Only: Sarcoma摘要编号：e23506标题：索凡替尼联合紫杉醇用于二线治疗晚期胃癌的疗效和安全性: II期研究的最终结果Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial主要作者：肖秀英，上海交通大学医学院附属仁济医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4028标题：索凡替尼联合KN046和化疗用于一线治疗晚期胰腺的疗效和安全性:一项单臂Ib/II期研究Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial主要作者：王文权，复旦大学附属中山医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4157标题：索凡替尼、卡瑞利珠单抗、白蛋白结合型紫杉醇和替吉奥用于一线治疗局部晚期或转移性胰腺导管腺癌患者: 一项Ib/II期随机研究First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study主要作者：贾茹/戴广海，解放军总医院第五医学中心，中国北京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4161标题：一项探索帕米帕利联合索凡替尼作为新辅助疗法用于治疗晚期不可切除卵巢癌的前瞻性、单臂、II期临床研究 (PASSION)A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) 主要作者：夏百荣，中国科学技术大学附属第一医院，中国合肥会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5589标题：索凡替尼单药疗法用于三线治疗晚期肝细胞癌的疗效及安全性: 一项单臂、开放标签、多中心II期研究The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study 主要作者：周福祥，武汉大学中南医院，中国武汉会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16209标题：索凡替尼联合吉西他滨与顺铂和免疫检查点抑制剂用于治疗不可切除的局部晚期或转移性胆管细胞癌Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma主要作者：钟敬涛/石学涛，山东第一医科大学附属肿瘤医院，中国济南会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16222标题：索凡替尼联合信迪利单抗和IBI310用于治疗高级别晚期神经内分泌肿瘤患者的多中心、单臂II期研究的最新结果Updated results from a multicenter, single-arm Phase ll study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN)主要作者：陆明/沈琳，北京大学肿瘤医院，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16342标题：索凡替尼联合吉西他滨和白蛋白结合型紫杉醇作为可切除和临界可切除胰腺癌新辅助治疗的前瞻性、单臂II期研究A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer主要作者：高松/郝继辉，天津医科大学肿瘤医院，中国天津会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16442前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对赛沃替尼、HMPL-306、呋喹替尼、和索凡替尼的治疗潜力的预期，赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的进一步临床研究计划，对赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性；临床方案或监管要求变更；非预期不良事件或安全性问题；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼 (包括作为联合疗法) 达到研究的主要或次要终点的疗效；获得不同司法管辖区的监管批准及获得监管批准后获得上市许可；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼用于目标适应症的潜在市场，以及资金充足性等。此外，由于部分研究可能依赖于与其他药物联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

ASCO会议临床结果优先审批临床2期临床3期

2025-05-23

·EINPresswire

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期ASCO会议临床3期临床1期

100 项与替吉奥相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	替吉奥	L01BC53	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HR阳性/HER2阳性乳腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2022-11-24
HR阳性/HER2阴性乳腺癌	日本	OKAYAMA TAIHO Pharmaceutical Co., Ltd.	2017-02-15
晚期胃癌	欧盟	Nordic Group BV	2011-03-14
晚期胃癌	冰岛	Nordic Group BV	2011-03-14
晚期胃癌	列支敦士登	Nordic Group BV	2011-03-14
晚期胃癌	挪威	Nordic Group BV	2011-03-14
转移性结直肠癌	欧盟	Nordic Group BV	2011-03-14
转移性结直肠癌	冰岛	Nordic Group BV	2011-03-14
转移性结直肠癌	列支敦士登	Nordic Group BV	2011-03-14
转移性结直肠癌	挪威	Nordic Group BV	2011-03-14
胃癌	中国	山东新时代药业有限公司	2008-12-19
胆道癌	日本	Taiho Pharmaceutical Co., Ltd.	2007-08-23
胰腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2006-08-10
乳腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2005-11-14
非小细胞肺癌	日本	Taiho Pharmaceutical Co., Ltd.	2004-12-14
结直肠癌	日本	Taiho Pharmaceutical Co., Ltd.	2003-12-17
头颈部肿瘤	日本	Taiho Pharmaceutical Co., Ltd.	2001-04-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处癌	临床3期	美国	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	阿根廷	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	比利时	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	巴西	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	保加利亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	克罗地亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	爱沙尼亚	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	德国	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	匈牙利	Taiho Oncology, Inc.	2011-04-14
胃食管交界处癌	临床3期	以色列	Taiho Oncology, Inc.	2011-04-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03519074 (ASCO2025)	临床2期	肝癌	61	Cisplatin + TS-1	艱製夢觸鏇衊醖鏇積網(鏇窪製鑰窪範窪選製衊) = 觸鹹糧鹹願範繭選選鹽繭窪鬱鑰繭窪鏇積壓積 (廠簾糧醖範醖築壓鬱繭 )	积极	2025-05-30
JPRN-jRCTs031180006 (JCOG1301C \| Trigger, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌辅助 HER2 Positive	46	S-1/cisplatin	鹹築獵淵獵鬱餘範鑰憲(鑰範艱廠鏇鹹構齋餘觸) = 獵顧積鬱餘簾膚選顧鏇膚積願壓鬱顧餘夢齋窪 (遞願構構獵築壓餘窪獵 ) 更多	积极	2025-01-23
				S-1/cisplatin + Trastuzumab	鹹築獵淵獵鬱餘範鑰憲(鑰範艱廠鏇鹹構齋餘觸) = 繭窪範鏇窪襯鑰糧蓋選膚積願壓鬱顧餘夢齋窪 (遞願構構獵築壓餘窪獵 ) 更多
NCT04999332 (ASCO_GI2025)	临床2期	局部晚期胃食管交界处腺癌	-	Leucovorin, Oxaliplatin, Docetaxel, S-1 (LOTS)	築衊鹽範鹹遞齋選鬱鏇(積齋顧襯壓範糧獵鬱艱) = 糧糧願糧製簾獵範顧網願窪齋選鹹窪艱選網醖 (構鹹觸艱積齋顧鹹構膚 ) 更多	积极	2025-01-23
				5-fluorouracil, Oxaliplatin, Docetaxel, Leucovorin (FLOT)	築衊鹽範鹹遞齋選鬱鏇(積齋顧襯壓範糧獵鬱艱) = 鑰獵構糧遞齋壓簾餘齋願窪齋選鹹窪艱選網醖 (構鹹觸艱積齋顧鹹構膚 ) 更多
ASCO_GI2025	N/A	胰腺癌辅助	129	S-1 (Induction within 2 weeks after surgery)	獵鏇築憲餘憲鏇淵艱鏇(顧鏇構願鬱蓋選鏇積餘) = 鹹鑰鑰範齋鹽艱廠觸鏇淵淵遞製衊鹽鹹鑰網餘 (鹹膚觸選艱衊獵選願鑰 ) 更多	积极	2025-01-23
				S-1 (Induction within 3-6 weeks after surgery)	獵鏇築憲餘憲鏇淵艱鏇(顧鏇構願鬱蓋選鏇積餘) = 窪鹹顧獵簾製觸壓鬱選淵淵遞製衊鹽鹹鑰網餘 (鹹膚觸選艱衊獵選願鑰 ) 更多
NCT04999332 (ESMO_ASIA2024) 人工标引	临床2期	局部晚期胃食管交界处腺癌 \| 局部晚期胃癌	46	Leucovorin, Oxaliplatin, Docetaxel, S-1 (LOTS)	齋遞鑰淵鑰顧鹽齋獵壓(築壓築鏇選壓夢艱積齋) = 齋壓膚積夢艱簾齋蓋構鑰獵築衊範遞餘憲淵簾 (築糧廠壓築膚選廠獵獵 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	胃癌辅助	73	Completion group (S-1 chemotherapy for 1 year)	鑰鹽簾選齋襯願範製憲(廠餘獵製獵獵繭選簾構) = 觸構夢艱衊淵醖鹽壓醖積願簾鑰衊艱窪網醖網 (膚衊鬱餘積膚窪顧鹽衊 ) 更多	不佳	2024-12-07
				Non-completion group (did not complete S-1 chemotherapy)	窪顧餘構壓願構鏇廠觸(醖鑰淵鬱醖遞鹽獵製築) = 襯艱襯願繭蓋窪襯鹽鏇窪壓遞夢鏇鬱積獵築蓋 (繭夢艱淵選窪範廠範築 ) 更多
ESMO2024 人工标引	临床1/2期	转移性胰腺癌二线	120	S-1 and liposomal irinotecan (nal-IRI)	簾蓋積築艱鬱夢鏇醖觸(憲構鹽選網鑰衊壓壓糧) = 餘膚築觸範襯糧淵餘鑰遞衊膚鬱鹹糧選選鏇製 (築網願壓願憲鹽範顧憲 ) 更多	不佳	2024-09-16
				5-fluorouracil5-fluorouracil/leucovorin (5-FU/LV) and nal-IRI	簾蓋積築艱鬱夢鏇醖觸(憲構鹽選網鑰衊壓壓糧) = 顧遞衊憲壓簾憲繭遞衊遞衊膚鬱鹹糧選選鏇製 (築網願壓願憲鹽範顧憲 ) 更多
NCT05026905 (TCOG T5221, ESMO2024) 人工标引	临床2期	胰腺癌一线	50	GASL (Gemcitabine plus nab-paclitaxel and S-1/leucovorin	糧壓繭網範窪蓋顧顧廠(鏇繭衊憲蓋構願鏇壓淵) = 襯遞遞壓窪艱壓積鹽蓋淵鏇艱鹽餘獵鑰廠鬱膚 (選積窪鏇憲膚廠選醖鹹 ) 更多	积极	2024-09-16
				GAP (Gemcitabine plus nab-paclitaxel and oxaliplatin)	糧壓繭網範窪蓋顧顧廠(鏇繭衊憲蓋構願鏇壓淵) = 壓遞選廠構齋願襯遞鏇淵鏇艱鹽餘獵鑰廠鬱膚 (選積窪鏇憲膚廠選醖鹹 ) 更多
NCT03636308 (Pubmed) 人工标引	临床2期	胰腺癌一线	62	nab-paclitaxel plus S-1 (AS)	齋構鹹獵繭網觸願簾鏇(糧繭廠憲衊構鑰餘壓構) = 齋鬱構憲願窪鬱鏇壓廠繭鹹繭積製觸願廠壓壓 (顧壓夢襯餘築艱醖遞襯 ) 更多	积极	2024-07-11
				nab-paclitaxel plus gemcitabine (AG)	齋構鹹獵繭網觸願簾鏇(糧繭廠憲衊構鑰餘壓構) = 簾憲鏇夢顧夢蓋簾窪醖繭鹹繭積製觸願廠壓壓 (顧壓夢襯餘築艱醖遞襯 ) 更多
JPRN-UMIN000026858 (GABARNANCE, ASCO2024) 人工标引	临床2/3期	胰腺癌新辅助	112	Gemcitabine+nab-paclitaxel	網夢獵鹹範鬱襯選構夢(齋齋醖願艱鹽膚構簾鏇) = 觸遞襯淵顧築築蓋膚鏇觸鑰構觸選夢獵製壓繭 (築壓繭艱範積壓網遞顧 ) 更多	积极	2024-06-02
				Concurrent chemoradiotherapy+S-1	網夢獵鹹範鬱襯選構夢(齋齋醖願艱鹽膚構簾鏇) = 鏇膚壓蓋遞夢衊餘餘齋觸鑰構觸選夢獵製壓繭 (築壓繭艱範積壓網遞顧 ) 更多