预约演示

更新于：2026-10-21

Durvalumab

度伐利尤单抗

更新于：2026-10-21

概要

基本信息

药物类型

单克隆抗体

别名

Durvalumab (Genetical Recombination)、Durvalumab (genetical recombination) (JAN)、Durvalumab (USAN/INN)

+ [10]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [12]

在研适应症

非肌层浸润性膀胱肿瘤胃癌早期胃癌+ [193]

非在研适应症

急性髓性白血病肺腺癌前列腺腺癌+ [101]

原研机构

AstraZeneca UK Ltd.

在研机构

Celgene Corp.

Exelixis, Inc.

NeoTX Therapeutics Ltd.

+ [19]

非在研机构

Mirati Therapeutics, Inc.

AIO-Studien-gGmbH

MedPacto, Inc.

+ [7]

权益机构

MedImmune Pharma BV

Ultimovacs ASAVall d'Hebron Institut d'Oncologia

+ [14]

最高研发阶段批准上市

首次获批日期

美国 (2017-05-01),

尿路上皮癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 10069506H

来源: *****

Sequence Code 13384675L

来源: *****

关联

938

项与度伐利尤单抗相关的临床试验

NCT07639528

/ Not yet recruiting临床2期IIT

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

[+1]

NCT05403723

/ Suspended临床1期IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

开始日期2027-01-30

申办/合作机构

University of Maryland Baltimore

[+1]

NCT07625930

/ Not yet recruiting临床2期IIT

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma

Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed.
This study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival.
In this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer.
If successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.

开始日期2027-01-01

申办/合作机构-

100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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2,439

项与度伐利尤单抗相关的文献（医药）

2026-12-31·ANNALS OF MEDICINE

Dose-Registered CT assessment of radiation-induced lung injury after chemoradiotherapy for stage III NSCLC

Article

作者: Sugahara, Shinji ; Ikeda, Norihiko ; Itonaga, Tomohiro ; Okubo, Mitsuru ; Zama, Tatsuhiko ; Mikami, Ryuji ; Saito, Kazuhiro

AIMS:

To quantify radiation-induced lung injury (RILI) on deformably registered CT images after chemoradiotherapy (CCRT) for stage III NSCLC, and to evaluate spatial and dosimetric associations between RILI and planned dose distribution in a pre-durvalumab cohort.

METHODS:

This retrospective study included 58 patients with stage III NSCLC treated with CCRT using three-dimensional conformal radiotherapy (3D-CRT) prior to the era of consolidation immunotherapy. Follow-up CT images at 6 months (acute) and 12 months (late) were registered to treatment planning CT using deformable image registration (DIR). RILI was quantified by segmented volume (mL) and isodose-line overlap (%). Dosimetric parameters (V5Gy-V60Gy, mean lung dose) and symptomatic RILI (CTCAE grade ≥2) were analysed using correlation, ROC, and logistic regression methods.

RESULTS:

Symptomatic RILI occurred in 14 patients (24.1%). RILI volume decreased by 27.7% from the acute to the late phase, with moderate-to-strong dose-volume correlations in both phases (Spearman ρ = 0.69-0.76). Symptomatic patients showed broader spatial spread into lower-dose regions (median isodose-line overlap 20% vs 40%; p < 0.001). Acute-phase RILI reaching the ≤25% isodose line (≤16.5 Gy) was an exploratory imaging marker in this cohort (AUC 0.81) that remained associated with symptomatic RILI on multivariable analysis (p < 0.01).

CONCLUSIONS:

Dose-registered CT analysis demonstrated consistent spatial associations between planned dose and RILI, providing a hypothesis-generating dosimetric-radiographic reference dataset that requires external validation in IMRT/VMAT- and durvalumab-treated cohorts before clinical application.

2026-12-31·OncoImmunology

Circadian timing of first-line chemoimmunotherapy is associated with survival in extensive-stage small cell lung cancer

Article

作者: Engin Delipoyraz, Ebru ; Fidan, Sena ; Cakir, Tansel ; Terzioglu, Cihat ; Cakan Demirel, Burcin ; Muglu, Harun ; Kutlu, Yasin ; Hamdard, Jamshid ; Ozcelik, Hakan ; Seker, Mesut ; Sunger, Erdem ; Yucel, Mehmet Haluk ; Bilici, Ahmet ; Acıkgoz, Ozgur ; Mildanoglu, Maral Martin

Growing evidence suggests that circadian timing influences the efficacy of immune checkpoint inhibitors across multiple malignancies. However, evidence in extensive-stage small cell lung cancer (ES-SCLC) remains limited to a single East Asian cohort, and independent validation in other populations is lacking. We conducted a retrospective single-center cohort study of 107 patients with ES-SCLC treated with first-line platinum-etoposide plus atezolizumab or durvalumab. The time of day of administration (ToDA) was defined as the median start time of the first four immunotherapy infusions, and patients were categorized according to the cohort median ToDA. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The cohort median ToDA was 11:54. Patients treated before the median ToDA had significantly longer median PFS (9.07 vs. 7.23 months, p = 0.002) and OS (21.17 vs. 11.43 months, p = 0.002) than those treated later. In multivariable Cox regression analysis, later administration remained independently associated with shorter PFS (adjusted HR 1.63, 95% CI 1.03-2.58; p = 0.038) and OS (adjusted HR 1.65, 95% CI 1.00-2.71; p = 0.049), whereas objective response rates, treatment-related toxicity, and immune-related adverse events were comparable between groups. Morning administration of first-line chemoimmunotherapy was associated with significantly longer survival without increased toxicity in patients with ES-SCLC. These findings support growing evidence that circadian timing may influence immune checkpoint inhibitor efficacy and warrant prospective evaluation of treatment timing as a readily modifiable strategy to optimize immunotherapy delivery.

2026-12-01·SEMINARS IN ONCOLOGY

Early hepatic decompensation is associated with mortality in patients with HCC treated with atezolizumab plus bevacizumab or durvalumab plus tremelimumab

Article

作者: Persano, Mara ; Ponziani, Francesca R ; Rimassa, Lorenza ; Pinato, David J ; Rocchetto, Simone ; Camera, Silvia ; Vitale, Alessandro ; Alimenti, Eleonora ; Lampertico, Pietro ; Cabibbo, Giuseppe ; Rimini, Margherita ; Iavarone, Massimo ; Casadei-Gardini, Andrea

BACKGROUND:

This study investigates the incidence and impact of early clinical hepatic decompensation (eCHD) on overall survival (OS) in patients with hepatocellular carcinoma (HCC) treated with immune-based therapies.

METHODS:

A retrospective analysis using TriNetX data included patients with HCC receiving atezolizumab plus bevacizumab (AB) or tremelimumab plus durvalumab (STRIDE) as their first recorded systemic treatment in the database. Primary outcomes were eCHD incidence and its association with OS. Secondary objectives included comparing baseline characteristics according to eCHD occurrence and evaluating outcomes for each treatment regimen by direct comparison and after propensity-score matching (PSM).

RESULTS:

Among 1,553 patients (1,246 AB and 307 STRIDE), eCHD occurred in 31% of each cohort and most commonly presented as ascites (variceal bleeding: 13.5% with AB vs. 10.5% with STRIDE). Patients with eCHD had worse baseline liver function and shorter median OS than patients without eCHD (AB: 5.5 vs. 16.2 months; STRIDE: 5.2 vs. 13.6 months), and the associations remained statistically significant after PSM for albumin and bilirubin. Among patients with eCHD, no statistically significant difference in OS was observed between treatment cohorts; however, this comparison should be interpreted cautiously. In the AB cohort, patients meeting the treatment-based surrogate definition of early progression had a significantly lower hazard of death than patients with eCHD (early progression versus eCHD; reference group: eCHD; HR 0.59, 95% CI 0.46-0.75, p=0.0002). In the smaller STRIDE cohort, the direction of the association was similar but did not reach statistical significance (early progression versus eCHD; reference group: eCHD; HR 0.58, 95% CI 0.30-1.12). These comparisons were exploratory because early progression was defined using a treatment-based surrogate.

CONCLUSIONS:

eCHD was associated with poor OS in patients with HCC treated with AB or STRIDE. The association remained statistically significant after matching for albumin and bilirubin, although residual confounding cannot be excluded.

3,722

项与度伐利尤单抗相关的新闻（医药）

2026-10-20

·ioncology

ESMO瞭望前瞻丨肝胆肿瘤研究全景扫描：哪些重磅数据即将揭晓？

编者按：2026年欧洲肿瘤内科学会（ESMO）年会将于10月23日至27日在西班牙马德里召开。本届大会肝胆肿瘤领域看点密集：周俭院士团队HARMONi-GI1研究入选LBA口头报告，探索依沃西单抗联合化疗一线治疗晚期胆道癌；ACTICCA-1、OPTIMUM、EMERALD-3、LEAP-012及C-CAR031等研究也将公布关键生存与疗效数据。壁报和电子壁报则覆盖双特异性抗体、联合介入及真实世界研究等方向。后续重磅数据将陆续揭晓，欢迎持续关注《肿瘤瞭望》来自马德里的现场报道。口头报告（Oral）胆道肿瘤摘要号：LBA8 英文标题：Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) 中文标题：依沃西单抗联合化疗对比度伐利尤单抗联合化疗作为晚期胆道癌的一线治疗：一项随机、对照、双盲、Ⅲ期试验（HARMONi-GI1）讲者：周俭单位：复旦大学附属中山医院摘要号：LBA21 英文标题：Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and gallbladder carcinoma (ACTICCA-1 trial) 中文标题：胆管癌及胆囊癌根治性切除术后，吉西他滨联合顺铂辅助化疗对比标准治疗方案（ACTICCA-1研究）讲者：Henning Wege 单位：University Medical Center Hamburg-Eppendorf 摘要号：LBA22 英文标题：OPTIMUM: A randomized phase 2 study of maintenance olaparib (Ola) with or without durvalumab (Durva) in DDR gene-mutated advanced biliary tract cancer (aBTC) 中文标题：OPTIMUM 研究：DDR基因突变晚期胆道癌（aBTC）中，奥拉帕利（Ola）联合或不联合度伐利尤单抗（Durva）维持治疗的一项随机Ⅱ期研究讲者：Changhoon Yoo 单位：Asan Medical Center 摘要号：473RO 英文标题：Subcutaneous anti-PD-L1 monoclonal antibody Envafolimab plus gemcitabine and oxaliplatin (GEMOX) versus GEMOX alone as first-line treatment for advanced biliary tract cancer in Chinese patients: A randomized, open-label, multicenter, registrational phase III trial 中文标题：皮下注射PD-L1单克隆抗体恩沃利单抗联合吉西他滨+奥沙利铂（GEMOX）对比单用GEMOX一线治疗中国晚期胆道恶性肿瘤患者：一项随机、开放标签、多中心、注册性Ⅲ期临床试验讲者：秦叔逵单位：浙江钱塘高等研究院上下滑动查看研究详情研究背景胆道系统肿瘤（BTC）在中国疾病负担居高不下。多数患者确诊时已处于晚期、不可切除阶段。GEMOX方案是临床广泛应用的一线化疗方案，相比顺铂类方案，该方案肾脏耐受性更优。恩沃利单抗是全球首款皮下注射抗PDL1抗体。本研究报告一项注册性Ⅲ期临床试验的最终分析结果，评估皮下注射恩沃利单抗联合GEMOX方案对比单用GEMOX方案治疗晚期胆道系统肿瘤的疗效。研究方法入组未接受过治疗、不可切除的局部晚期或转移性胆道系统肿瘤中国患者，按1:1比例随机分为两组：试验组给予皮下注射恩沃利单抗（2.5 mg/kg，每周1次）联合GEMOX方案（吉西他滨1000 mg/m²，第1、8天给药；奥沙利铂85 mg/m²，第1天给药，每3周为1周期）；对照组仅使用GEMOX方案。化疗最多进行6个周期。分层因素包括肿瘤原发部位、疾病分期、既往治疗史以及ECOG体力状态评分。主要研究终点为总生存期（OS）。次要研究终点包括无进展生存期（PFS）、由盲态独立中心审查委员会（BICR）依据RECIST v1.1标准评估的客观缓解率（ORR）以及安全性。研究结果共计472例患者完成随机分组，其中462例患者接受治疗（恩沃利单抗+GEMOX组232例；GEMOX单药组230例）。本研究达到主要研究终点。相较于单用GEMOX方案，恩沃利单抗联合GEMOX方案可显著延长患者OS（中位OS：10.9个月对比8.6个月；HR=0.723，95%CI：0.5850.880；P=0.0016）。两组12个月、24个月、36个月OS率分别为44.2% vs 29.9%，19.9% vs 10.8%，12.5% vs 7.7%。ORR提升至27.6%，对照组为20.9%。恩沃利单抗组获得缓解的患者疗效持续时间更长（中位缓解持续时间DoR：5.5个月对比4.2个月）。整体安全性可控，与既往已知的药物安全性特征一致，未发现新的安全风险信号。恩沃利单抗+GEMOX组免疫相关不良反应（irAEs）发生率为20.7%。研究结论在GEMOX化疗基础上加用皮下注射恩沃利单抗，可为晚期胆道系统肿瘤患者带来显著总生存获益。该联合方案安全性可控，同时皮下给药方式具备使用便捷性，恩沃利单抗联合GEMOX方案有望成为该类患者极具优势、疗效优异的一线标准治疗方案。肝癌摘要号：LBA48 英文标题：Liver function trajectory and post-progression outcomes in the Phase 3 EMERALD-3 study of tremelimumab (T) + durvalumab (D) ± lenvatinib (L) + transarterial chemoembolisation (TACE) in participants (pts) with embolisation-eligible hepatocellular carcinoma (eeHCC) 中文标题：符合栓塞治疗指征肝细胞癌（eeHCC）患者的Ⅲ期EMERALD-3研究：曲美木单抗（T）+度伐利尤单抗（D）±仑伐替尼（L）联合经动脉化疗栓塞术（TACE）的肝功能变化轨迹与疾病进展后结局讲者：Masatoshi Kudo 单位：日本近畿大学摘要号：1678RO 英文标题：Phase 3 LEAP-012 Study of Lenvatinib + Pembrolizumab vs Dual Placebo With Transarterial Chemoembolization (TACE) for Unresectable Non-metastatic Hepatocellular Carcinoma: Long-term OS Results 中文标题：仑伐替尼联合帕博利珠单抗对比双安慰剂联合经动脉化疗栓塞（TACE）用于不可切除非转移性肝细胞癌的Ⅲ期LEAP-012研究长期总生存（OS）结果讲者：Josep M. Llovet 单位：西班牙巴塞罗那大学临床医院上下滑动查看研究详情研究背景全球Ⅲ期LEAP012研究（NCT04246177）纳入不可切除、无转移肝细胞癌（HCC）受试者。首次中期分析（IA1；预设的PFS最终分析，数据截止日期：2024年1月30日）结果显示：仑伐替尼+帕博利珠单抗+TACE组，对比双安慰剂+TACE组，盲态独立中心审查委员会依据RECIST v1.1标准评估的PFS获得显著改善（HR=0.66；95%CI：0.510.84；单侧P=0.0002）。本文报告第三次中期分析（IA3）的OS结果，数据截止时间：2025年8月19日。研究方法符合入组标准的患者为无法接受根治性治疗、病灶仅局限于肝脏、无门静脉侵犯、ChildPugh A级、ECOG体力状态0或1分的无转移HCC患者。按1:1随机分组：试验组接受TACE+帕博利珠单抗400 mg静脉输注，每6周1次；仑伐替尼，体重≥60 kg每日口服12 mg，体重＜60 kg每日口服8 mg。对照组接受TACE+口服安慰剂+静脉安慰剂，两组治疗时长均不超过2年。主要研究终点为盲态独立中心审查委员会依据RECIST v1.1标准评估的PFS以及OS。次要研究终点包括盲态独立中心审查委员会依据RECIST v1.1标准评估的ORR、DoR、至疾病进展时间以及安全性。研究结果共计480例患者接受治疗，仑伐替尼+帕博利珠单抗+TACE组237例，安慰剂+TACE组243例。中位随访时长44.2个月（范围31.362.1个月）。数据截止时，共发生253例OS事件；仑伐替尼+帕博利珠单抗组与安慰剂组的中位OS分别为40.4个月对比40.8个月（HR=0.98；95%CI：0.761.26）。疗效数据详见表格。第三次中期分析中盲态独立中心审查委员会依据RECIST v1.1标准评估的PFS描述性分析结果，与首次中期分析结果保持一致。≥3级治疗相关不良事件发生率分别为72.2%和32.0%。因治疗相关不良事件终止治疗的患者，两组分别为21例（8.9%）和4例（1.7%）。仑伐替尼+帕博利珠单抗组发生4例（1.7%）治疗相关死亡，安慰剂组发生2例（0.8%）。研究结论 LEAP012研究达到PFS获益的主要终点，但未观察到OS获益。约40个月的中位OS，为不可切除无转移HCC的临床试验设计建立了新参照标准。仑伐替尼联合帕博利珠单抗的安全性特征与既往报道及LEAP012早期分析结果保持一致。摘要号：1680RO 英文标题：Phase I study of C-CAR031, a GPC3-targeted TGFβRIIDN armored autologous CAR-T, in advanced hepatocellular carcinoma (aHCC): Updated Results 中文标题：靶向GPC3并携带TGFβRIIDN的武装自体CAR-T（C-CAR031）在晚期肝细胞癌中的Ⅰ期研究更新结果讲者：Qi Zhang 单位或地区：中国杭州上下滑动查看研究详情研究背景 CCAR031是一款靶向GPC3、携带显性负性TGFβII型受体的装甲型自体CART细胞产品，用于克服肿瘤微环境中由TGFβ介导的免疫抑制。本研究报告该产品用于晚期HCCⅠ期研究的更新安全性与疗效数据，包含延长随访后的生存分析结果。研究方法本项人体首次、开放标签、剂量爬坡试验采用加速滴定联合i3+3试验设计。既往接受≥1线全身治疗失败的GPC3阳性晚期HCC患者，在接受标准淋巴细胞清除预处理后，静脉输注CCAR031。主要研究终点为安全性与耐受性；其他终点包括药代动力学以及初步疗效。研究结果截至2026年3月25日，共有36例患者接受4个剂量水平（DL）的CCAR031治疗，中位随访时间14个月。94%患者为BCLC C期，83%存在肝外转移；既往中位治疗线数为4线（范围18线），92%既往接受过免疫检查点抑制剂（ICIs）和酪氨酸激酶抑制剂（TKIs）治疗。依据ASTCT2019标准，36例患者中94%发生细胞因子释放综合征（CRS），4剂量组有6%患者出现3级CRS；未观察到免疫效应细胞相关神经毒性综合征（ICANS），也未出现剂量限制性毒性。按照CTCAEv5.0标准，最常见≥3级治疗期间出现的不良事件为淋巴细胞减少（100%）、白细胞减少（81%）以及中性粒细胞减少（72%）；与CCAR031相关最常见≥3级不良事件为血小板减少（11%）、转氨酶升高（14%）。4剂量组有2例（6%）发生与CCAR031相关的间质性肺病。1例患者因CCAR031相关肿瘤溶解综合征继发肾功能损伤，因拒绝透析治疗死亡。 89%的患者观察到肿瘤缩小，肿瘤中位缩小幅度42%（范围3%94%）。疾病控制率92%，依据RECIST v1.1标准评估的客观缓解率为44%。更新后的生存数据将在大会上展示。研究结论 CCAR031用于经多线治疗的晚期HCC患者，安全性整体可控，展现出强劲的临床疗效。该产品的后续开发工作正在推进。壁报（Poster）胆道肿瘤摘要号：470P 英文标题：Iparomlimab and Tuvonralimab (QL1706) Combined with Lenvatinib and GEMOX as First-line Treatment for Advanced Biliary Tract Cancer (SPRING): A Multi-Center, Single-arm, Phase 2 Study 中文标题：艾帕洛利托沃瑞利单抗（QL1706）联合仑伐替尼与GEMOX方案一线治疗晚期胆道恶性肿瘤（SPRING研究）：一项多中心、单臂Ⅱ期临床研究讲者：Yizhou Wang 单位或地区：中国上海上下滑动查看研究详情研究背景免疫检查点抑制剂联合化疗已获批用于晚期BTC的一线治疗。SPRING研究旨在评估双功能抗PD1/CTLA4抗体QL1706联合仑伐替尼与GEMOX方案治疗该疾病患者的疗效与安全性。研究方法本项多中心、单臂Ⅱ期研究入组符合条件的患者：年龄≥18岁，初治、局部晚期不可切除或转移性BTC，ECOG体力状态评分为0或1分，依据RECIST v1.1标准至少存在1处可测量病灶。患者接受：吉西他滨1 g/m²静脉输注，第1、8天，每3周1次；奥沙利铂85 mg/m²静脉输注，第1天，每3周1次；QL1706 5 mg/kg静脉输注，第1天，每3周1次；仑伐替尼8 mg口服，每日一次。后续继续使用QL1706联合仑伐替尼，直至疾病进展或出现不可耐受毒性。主要研究终点为ORR。次要研究终点包括疾病控制率（DCR）、至缓解时间（TTR）、DoR、PFS、OS以及安全性。研究结果 2025年6月2026年3月期间，共入组41例患者。数据截止时间（2026年3月25日），中位随访时间3.8个月。患者中位年龄59岁（范围2976岁），男性占46.3%。肿瘤原发类型：肝内胆管癌28例（68.3%），肝外胆管癌4例（9.8%），胆囊癌9例（22.0%）。 36例可评估疗效的患者中，ORR为52.8%，DCR为100.0%；其中完全缓解1例（2.8%），部分缓解18例（50.0%），疾病稳定17例（47.2%）。2例肿瘤显著缩小的患者成功接受转化手术。中位TTR为2.6个月（IQR：1.63.1）。中位PFS尚未达到，OS数据尚不成熟。任意级别治疗相关不良事件（TRAEs）发生率84.6%，≥3级TRAEs发生率33.3%。发生率≥20%的常见TRAEs为中性粒细胞计数下降、白细胞计数下降、蛋白尿以及血小板计数下降。无TRAEs导致治疗终止或死亡事件。研究结论 QL1706联合仑伐替尼与GEMOX方案，在初治晚期BTC患者中展现出良好的抗肿瘤活性，安全性可控。摘要号：472P 英文标题：Promising preliminary phase II clinical activity of opamtistomig (LBL-024), a PD-L1×4-1BB bispecific antibody, plus gemcitabine–cisplatin in first-line advanced biliary tract cancer 中文标题：PD-L1×4-1BB双特异性抗体opamtistomig（LBL-024）联合吉西他滨-顺铂一线治疗晚期胆道恶性肿瘤，Ⅱ期临床研究展现可观初步抗肿瘤疗效讲者：周俭单位：复旦大学附属中山医院上下滑动查看研究详情研究背景 BTC是一种侵袭性强的免疫“冷肿瘤”，治疗选择有限，预后较差。尽管PD(L)1抑制剂联合化疗可小幅改善患者结局，但持久获益有限。opamtistomig（LBL024）为新型PDL1×41BB双特异性抗体，分子构型为2:2，经过高度优化，PDL1与41BB亲和力比值为300:1，优先结合PDL1，可实现条件性激活41BB，同时最大限度降低全身毒性，旨在将免疫冷肿瘤转化为免疫应答型肿瘤。本Ⅱ期研究评估opamtistomig联合吉西他滨+顺铂（GC）方案一线治疗晚期BTC，本文报告初步疗效与安全性数据（NCT07111546）。研究方法本Ⅱ期研究中，患者接受opamtistomig（15 mg/kg，静脉输注，每3周1次）联合吉西他滨（1000 mg/m²，静脉输注）和顺铂（25 mg/m²，静脉输注），3周为1周期，最多治疗8个周期，之后使用opamtistomig进行维持治疗。主要研究终点为安全性和ORR。研究结果截至2026年4月1日，安全性导入阶段共入组20例患者（胆囊癌2例、肝内胆管癌13例、肝外胆管癌5例）。患者中位年龄61岁，男性占70.0%，85.0%患者存在转移。所有患者均发生治疗期间出现的不良事件（TEAEs），其中≥3级不良事件发生率75.0%；最常见的≥3级TEAEs为白细胞减少、中性粒细胞减少以及贫血。ORR为55.0%，DCR为100.0%；PDL1阳性患者ORR达到100%。扩展队列计划最多入组50例患者。研究结论 opamtistomig联合GC方案在晚期BTC中展现出极具前景的初步抗肿瘤活性，安全性可控。PDL1阳性患者ORR达100%，凸显PDL1×41BB条件性共靶向的价值，提示opamtistomig有潜力成为BTC领域同类首创或同类最优药物。更新后的生存数据以及扩展队列结果将在欧洲肿瘤内科学会（ESMO）大会公布。肝癌摘要号：1682P 英文标题：Neoadjuvant QL1706 (Iparomlimab-Tuvonralimab) Plus Lenvatinib for Potentially Resectable Hepatocellular Carcinoma: Preliminary Results from an Exploratory Phase II Study 中文标题：QL1706（艾帕洛利托沃瑞利单抗）联合仑伐替尼新辅助治疗潜在可切除肝细胞癌：一项探索性Ⅱ期临床研究初步结果讲者：Chengjie Li 单位或地区：中国北京上下滑动查看研究详情研究背景以免疫检查点抑制剂为基础的联合治疗可使HCC患者获得较高的客观缓解率。QL1706是一款同时靶向PD1与CTLA4的新型双功能抗体。本研究评估QL1706联合仑伐替尼新辅助治疗潜在可切除HCC患者的疗效与安全性。研究方法本研究为单臂、开放标签Ⅱ期研究（NCT07014150）。入组存在高危因素（例如肿瘤＞5 cm，或大血管侵犯）的潜在可切除HCC患者，接受新辅助治疗：QL1706（7.5 mg/kg，静脉输注，每3周1次）联合仑伐替尼（8 mg或12 mg，口服，每日一次）。计划术前完成3个周期（9周）的新辅助治疗。研究结果数据截止时，共入组33例患者，其中25例完成计划的3周期新辅助治疗。这25例患者中位年龄58岁（IQR：4770），男性占92%（23例）。依据RECIST v1.1标准评估ORR为52%。另有1例患者达到完全缓解（CR），免于手术。截至目前，14例患者顺利完成手术切除，主要病理缓解（MPR，残留存活肿瘤细胞≤10%）率43%（6/14），病理完全缓解（pCR）率29%（4/14）。其余患者等待手术或正在进行评估。该联合方案安全性可控。任意级别治疗相关不良事件（TRAEs）发生率92%；≥3级TRAEs发生率24%，主要为AST升高（12%）、ALT升高（12%）、皮疹（8%）。无治疗相关死亡事件发生。研究结论 QL1706联合仑伐替尼新辅助治疗潜在可切除HCC，抗肿瘤活性令人鼓舞，ORR较高，安全性良好。患者治疗与数据收集仍在继续，进一步验证该初步结果并优化治疗策略。电子壁报（ePoster）胆道肿瘤摘要号：514eP 英文标题：Iparolimab and Tuvonralimab (QL1706) Plus Hepatic Arterial Infusion Chemotherapy (HAIC) in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma 中文标题：艾帕洛利托沃瑞利单抗（QL1706）联合肝动脉灌注化疗（HAIC）治疗不可切除或转移性肝内胆管癌讲者：张宗利单位：山东大学齐鲁医院上下滑动查看研究详情研究背景肝内胆管癌（iCCA）预后差，一线治疗选择有限。HAIC可提升局部病灶控制效果，而双免疫检查点阻断能够增强全身免疫应答。本项单臂探索性研究评估艾帕洛利托沃瑞利单抗（QL1706）联合HAIC一线治疗不可切除或转移性iCCA的疗效。研究方法入组经病理确诊、未接受过iCCA相关全身治疗的ⅢBⅣ期不可切除或转移性iCCA患者，给予QL1706 5.0 mg/kg，第1天给药，每3周1次，联合HAIC，每3周为1周期，最多治疗8个周期。后续采用QL1706单药维持治疗（每3周1次），直至疾病进展或出现不可耐受毒性。每6周（±7天）进行肿瘤影像学评估。主要研究终点为依据RECIST v1.1评估的ORR。次要研究终点包括DOR、DCR、PFS、OS以及安全性（依据CTCAE5.0标准）。研究结果截至2026年5月7日，共入组32例iCCA患者。其中12例患者完成至少1次影像学评估，20例患者尚未达到首次影像学评估时间。已评估的12例患者中，男性7例（58.3%），女性5例（41.7%），中位年龄62.8岁（4374岁）。HAIC治疗中位次数为4次（35次）。基线时12例患者平均BMI为23.8±2.6，首次评估时下降至22.8±2.2。本研究将持续监测BMI与患者预后之间的相关性。10例患者达到PR，1例为SD。依据RECIST v1.1标准，ORR为83.3%（10/12），DCR为91.7%（11/12）。中位PFS与中位OS均尚未达到。34级治疗相关不良事件（TRAEs）发生率33.3%，包括恶心/呕吐伴食欲下降、皮疹、胸闷。未发生治疗相关死亡。研究结论 QL1706联合HAIC用于不可切除或转移性iCCA，展现出令人鼓舞的初步抗肿瘤活性，安全性可控。肝癌摘要号：1693eP 英文标题：JS207, a bispecific antibody targeting PD-1 and VEGF-A, combined with JS007 (anti-CTLA4), for patients with advanced hepatocellular carcinoma: updated results from a Phase Ⅱ study 中文标题：靶向PD-1/VEGF-A双特异性抗体JS207联合抗CTLA4单抗JS007治疗晚期肝细胞癌：Ⅱ期研究更新结果讲者：周俭单位：复旦大学附属中山医院上下滑动查看研究详情研究背景 JS207是靶向PD1和VEGFA的双特异性抗体。本Ⅱ期研究（NCT06954467）旨在评估JS207联合CTLA4抗体JS007治疗晚期HCC患者的安全性与疗效。研究方法本研究首先设置安全性导入阶段，入组69例患者，确定JS007的推荐剂量，用于后续随机扩展阶段；扩展阶段计划入组4060例患者。安全性导入阶段：JS207固定剂量10 mg/kg，每3周1次，联合JS007 3 mg/kg每6周1次，共给药2个周期；之后JS007以1 mg/kg每6周1次进行维持治疗。扩展阶段：患者按1:1随机分组，分别接受JS207联合JS007方案或JS207单药治疗。入组标准：经组织学或细胞学确诊的不可切除或转移性HCC，既往未接受过全身抗肿瘤治疗。主要研究终点为安全性以及研究者评估的ORR。研究结果截至2026年4月30日，共有35例（含安全性导入及扩展队列）患者接受JS207+JS007联合治疗，28例患者接受JS207单药治疗。两组＜65岁患者占比分别为62.9%、60.7%；BCLCC期患者占比分别为68.6%、60.7%。联合组与单药组治疗相关不良事件（TRAEs）发生率分别为82.9%、57.1%；≥3级TRAEs发生率分别为28.6%、7.1%；严重不良事件发生率分别为31.4%、10.7%。 JS207联合JS007组最常见TRAEs为天冬氨酸氨基转移酶（AST）升高（40.0%）、低白蛋白血症（34.3%）、发热（34.3%）；JS207单药组最常见TRAEs为AST升高（25.0%）、血胆红素升高（17.9%）、血小板计数下降（17.9%）。无治疗期间不良事件导致死亡的病例。联合组ORR为50.0%，单药组ORR为11.1%；两组DCR分别为88.5%、88.8%。研究结论 JS207联合JS007作为晚期HCC一线治疗，展现出良好的疗效，安全性可控。本研究随机扩展阶段仍在进行中。摘要号：1700eP 英文标题：Outcomes by baseline tumor burden using 6-and-12 scores and up-to-7 criteria in TALENTACE: Phase 3 study of on-demand TACE combined with atezolizumab+bevacizumab or on-demand TACE alone in patients with systemically untreated, unresectable HCC 中文标题：TALENTACE Ⅲ期研究中基线肿瘤负荷分层结局分析：按需TACE联合阿替利珠单抗+贝伐珠单抗对比单纯按需TACE治疗初治不可切除肝细胞癌（基于6/12评分及up-to-7标准）讲者：Sadahisa Ogasawara 单位：Chiba University Hospital 上下滑动查看研究详情研究背景 TACE仍是中期不可切除HCC（uHCC）的标准治疗方案，但患者生存结局个体差异大，很多患者预后仍不理想。TALENTACE研究评估TACE联合阿替利珠单抗+贝伐珠单抗（Atezo/Bev）（A组）对比单纯按需TACE（B组）用于uHCC患者的疗效与安全性。既往分析显示：肿瘤最大径总和+病灶数目≥6的患者中，A组相对B组可显著改善TACEPFS（从随机分组至出现不可再行TACE的疾病进展或任意原因死亡的时间）。肿瘤负荷是uHCC的预后因素，本文报告TALENTACE研究中按肿瘤负荷分层的疗效结果。研究方法 TALENTACE研究（NCT04712643）在中国与日本入组符合TACE治疗指征、未接受系统治疗、确诊HCC的患者；ECOG体力状态01分，ChildPugh A级。患者按1:1随机分组，接受TACE+Atezo/Bev或单纯TACE治疗。TACE由研究者根据临床需求按需实施。Atezo/Bev在TACE结束至少14天后、最长不超过8周内开始给药。研究结果采用6and12评分（≤6、＞612、＞12）以及upto7标准（≤7、＞7）对基线肿瘤负荷分层，评估疗效终点。不同基线肿瘤负荷亚组下A组对比B组的TACEPFS结果如下：≤6亚组：36.53个月 vs 8.84个月，HR无法计算；＞612亚组：14.52个月 vs 7.43个月，HR=0.71，95%CI：0.511.01；＞12亚组：6.47个月 vs 3.32个月，HR=0.71，95%CI：0.481.06；≤7亚组：14.52个月 vs 21.68个月，HR=0.94，95%CI：0.501.76；＞7亚组：8.97个月 vs 6.18个月，HR=0.70，95%CI：0.520.92。依据RECIST v1.1评估的PFS，在全部肿瘤负荷亚组中，A组均呈现数值上更优的趋势。采用RECICL及RECIST v1.1标准评估的ORR以及DpR，在全部肿瘤负荷亚组中A组均持续更高。研究结论在各基线肿瘤负荷亚组中，TACE联合Atezo/Bev对比单纯按需TACE，在TACEPFS、RECIST v1.1标准下PFS、ORR、DpR方面均观察到数值上获益趋势。摘要号：1705eP 英文标题：Overall survival associated with different treatment strategies in hepatocellular carcinoma: a real‑world study in China over 5 years 中文标题：肝细胞癌不同治疗方案对应的总生存结局：中国一项为期 5 年的真实世界研究讲者：冯璟单位：山西省人民医院上下滑动查看研究详情研究背景 HCC的治疗策略与生存结局差异较大。真实临床实践中，患者常接受介入治疗、全身治疗，或是二者联合方案。目前来自中国常规临床环境下的长期生存对比数据仍然有限。本研究基于地区真实世界HCC队列，评估不同治疗策略下的OS。研究方法回顾性纳入山西省人民医院确诊为HCC的患者。按照治疗方案将患者分为三组：单纯介入治疗组、介入联合全身治疗组、单纯全身治疗组。主要研究终点为OS。采用KaplanMeier法计算15年OS率；采用多因素Cox比例风险模型分析治疗模式与总生存之间的关联。研究结果共计293例患者纳入分析。患者中位年龄63岁，男性占72.0%，80.2%为BCLC B/C期；AFP中位水平36.6 ng/mL。单纯介入治疗组中位OS尚未达到（NR），介入联合全身治疗组中位OS为68.07个月，单纯全身治疗组中位OS为36.93个月。多因素Cox分析显示：AFP水平升高（log[Afp+1],HR=1.15,95%CI：1.031.27；P=0.009）、BCLC分期晚（C/D期对比非C/D期：HR=1.96,95%CI：1.063.65；P=0.033）是生存预后不良的独立相关因素。各治疗策略的1、2、3、4、5年OS率详见表格。研究结论本研究结果提示，真实世界中HCC患者的生存结局，相比单纯治疗策略，可能更多受肿瘤生物学特征与疾病分期影响，凸显了常规临床工作中风险分层的重要价值。摘要号：1709eP 英文标题：Nivolumab plus Ipilimumab with or without Interventional Therapy for Hepatocellular Carcinoma in later-line Setting: A Real-World Study 中文标题：纳武利尤单抗联合伊匹木单抗±介入治疗后线治疗肝细胞癌：一项真实世界研究讲者：Tianqing Wu 单位：中山大学肿瘤防治中心上下滑动查看研究详情研究背景纳武利尤单抗联合伊匹木单抗（Nivo/Ipi）是晚期HCC的标准一线治疗方案，但该方案在后线治疗中联合介入治疗的真实世界证据较为有限。本研究评估该治疗策略用于既往治疗进展后患者的疗效与安全性。研究方法本项回顾性研究纳入中山大学肿瘤防治中心2025年3月2026年3月，一线治疗失败后接受Nivo/Ipi治疗的HCC患者。将患者分为Nivo/Ipi单药组、Nivo/Ipi联合介入组（Nivo/Ipi+I）。主要研究终点为PFS；次要研究终点包括ORR、DCR以及安全性。分别采用RECIST v1.1和mRECIST标准评估肿瘤疗效。研究结果共纳入53例患者（Nivo/Ipi组37例；Nivo/Ipi+I组16例），两组基线特征均衡。依据RECIST v1.1评估：Nivo/Ipi+I组PFS得到改善（HR=0.17，95%CI：0.040.75；P=0.008），DCR更高（87.5% vs 51.4%，P=0.015）；两组ORR相近（12.5% vs 2.8%，P =0.213）。依据mRECIST评估：Nivo/Ipi+I组同样获得更优的PFS（HR=0.18，95%CI：0.040.80；P=0.012）、ORR（25.0% vs 2.8%，P=0.025）以及DCR（87.5% vs 54.1%，P=0.029）。两组总体不良事件发生率（81.2% vs 70.3%，P=0.510）、严重不良事件发生率（37.5% vs 16.2%，P=0.150）水平相当；但Nivo/Ipi+I组血小板计数下降（25.0% vs 2.7%，P=0.025）、低白蛋白血症（50.0% vs 13.5%，P=0.012）的发生更为多见。研究结论介入治疗联合Nivo/Ipi可以改善经治疗进展后HCC患者的临床结局，支持该方案作为后线治疗选择，兼具安全性与疗效。摘要号：1738eP 英文标题：Real-world conversion surgery, survival outcomes, and safety of atezolizumab plus bevacizumab with TACE in unresectable hepatocellular carcinoma 中文标题：阿替利珠单抗联合贝伐珠单抗联合TACE治疗不可切除肝细胞癌的真实世界转化手术率、生存结局与安全性讲者：杨欣荣单位：复旦大学附属中山医院上下滑动查看研究详情研究背景阿替利珠单抗联合贝伐珠单抗是不可切除HCC的标准一线治疗，但该方案用于转化为根治性切除的价值尚不明确。本研究旨在真实世界中评估阿替利珠单抗联合贝伐珠单抗联合按需经动脉化疗栓塞术（TACE），重点关注手术转化率。研究方法本多中心研究纳入121例接受阿替利珠单抗联合贝伐珠单抗±TACE治疗的不可切除HCC患者。主要研究终点为ORR。次要研究终点包括PFS、OS、手术转化情况以及安全性。研究结果一线治疗的疗效优于二线治疗：ORR更高（47.3% vs 22.2%），中位PFS更长（19.0 vs 8.8个月），OS更长（35.3 vs 13.0个月）。一线治疗人群中，95例接受阿替利珠单抗联合贝伐珠单抗+TACE，17例未联合TACE。联合TACE组ORR更高（50.5% vs 29.4%），PFS更长（20.9 vs 8.0个月），OS更长（35.3 vs 25.6个月），疗效数值上优于GO30140以及IMbrave150研究数据。值得关注的是，联合TACE组33.7%患者成功实现R0切除，未联合TACE组仅为5.9%。接受手术切除的患者中，病理完全缓解率为34.4%，主要病理缓解率为68.8%；影像学缓解与病理缓解不完全一致。单发病灶、基线CD8⁺T细胞浸润水平更高与ORR更优相关；ECOG体力状态、更低肿瘤负荷、更高CD4⁺及CD8⁺T细胞浸润与手术转化相关。联合TACE组与未联合TACE组3/4级治疗相关不良事件发生率分别为54.7%、52.9%，未发生5级不良事件。研究结论按需TACE联合阿替利珠单抗+贝伐珠单抗可使1/3初始不可切除HCC患者获得根治性切除机会，安全性可控，可获得较高比例的深度病理缓解，有望搭建通向外科根治的治疗桥梁。摘要号：1752eP 英文标题：Efficacy of iparomlimab/tuvonralimab injection (QL1706, a PD‑1/CTLA‑4 dual inhibitor) combined with intra-arterial interventional therapy and bevacizumab in hepatocellular carcinoma refractory to Tyrosine Kinase Inhibitors (TKIs) and PD-(L)1. 中文标题：QL1706（艾帕洛利托沃瑞利单抗，PD-1/CTLA-4双抗）联合动脉介入治疗与贝伐珠单抗用于酪氨酸激酶抑制剂、PD-(L) 1抑制剂耐药肝细胞癌的疗效研究讲者：张天奇单位：中山大学肿瘤防治中心上下滑动查看研究详情研究背景 HCC经一线TKIs联合PD(L)1治疗失败后，其二线及后线治疗相关证据尚不充分。本回顾性分析探究该类人群使用QL1706联合动脉介入治疗以及贝伐珠单抗的治疗效果。研究方法入组一线TKIs联合PD(L)1治疗耐药的HCC患者，序贯给予动脉介入治疗、贝伐珠单抗（BEV，7.5 mg/kg，动脉灌注，每3周1次）以及QL1706（5 mg/kg，静脉滴注，每3周1次），评估疗效（ORR、PFS、OS）与安全性。研究结果 2024年11月2025年12月，共纳入13例符合条件的患者，中位年龄54.5岁（范围：2770岁）。入组前一线治疗的中位持续时间12.37个月（范围：1.4027.93）。所有患者肝内肿瘤数目＞10个，肿瘤最大径均值6.83 cm（1.6015.28 cm）；BCLCC期10例，B期3例；ALBI 1级7例，ALBI 2级6例。截至2026年4月30日，中位随访时间8.0个月，全部患者均完成至少1次基线后肿瘤疗效评估。依据RECIST v1.1标准，确认ORR为38.46%，其中5例达到PR；依据mRECIST标准ORR为46.15%，包含2例（15.38%）CR、4例（30.77%）PR。无论采用RECIST v1.1还是mRECIST标准，DCR均为61.54%。依据RECIST v1.1评估的中位至缓解时间（mTTR）为2.97个月（IQR：2.103.13）；依据mRECIST评估mTTR为2.25个月（IQR：1.652.83）。RECIST v1.1与mRECIST标准下中位PFS均为6.17个月。中位OS尚未达到，12个月OS率为64.2%。 ≥3级不良事件（AEs）发生率38.46%，无5级不良事件。最常见3级不良事件为中性粒细胞下降（30.77%）；最严重不良事件为4级天冬氨酸氨基转移酶升高。研究结论 QL1706联合动脉介入治疗以及BEV，用于TKIs联合PD(L)1治疗后耐药的HCC，可带来较好疗效，安全性可接受。更多研究详情敬请关注ESMO 2026大会后续报道。《肿瘤瞭望》将持续带来现场前沿动态，敬请期待。（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期临床3期临床结果

2026-10-20

·CBA1995

突破与重塑｜美国华人生物医药科技协会（CBA）2026年科学研讨会即将召开——聚焦罕见病与基因治疗

01 会议概况从一个致病基因的发现，到真正改变患者命运的治疗方案，需要走多远？罕见病之“罕见”，不仅在于患者人数稀少，更在于其背后尚未被充分揭示的疾病机制、长期受限的科研资源，以及无数患者对有效治疗的迫切期待。每一种罕见病，既是现代医学尚未攻克的科学难题，也是探索人类生命奥秘的重要窗口；对罕见病的研究，不仅关乎少数患者的命运，更可能推动我们对基因功能、疾病发生机制及创新治疗策略的根本性认识。罕见的是疾病，但疾病的研究和治疗值得被看见；有限的是患者数量，但不应限制科学探索的深度与希望。 CBA的这次科学研讨会将汇聚顶尖科学家、临床医生、生物医药产业创新者以及具有丰富经验的监管专家，共同探讨治疗产品开发过程中的关键瓶颈。会议将围绕科学突破、CMC（化学、生产与质量控制）的规模化、临床转化衔接以及不断发展的监管框架等方面展开讨论，旨在重塑罕见病药物从实验室研究到临床应用（bench to bedside）的开发模式。欢迎大家一起来关注和探讨这个难题。此次CBA 科学研讨会主题是 “Breakthrough & Reshaping: Scientific Frontiers, Regulatory Boundaries, and Translational Innovations in Rare Diseases and Gene Therapy” 包括2个分论坛： Scientific Frontiers in Rare Diseases: From Disease Mechanisms to Novel Therapies Clinical & Regulatory Perspective: Accelerate Rare Disease Drug Development 02 会议时间地点 Date: November 7, 2026 Time: 8:00 AM – 2:00 PM ET Location: AstraZeneca JBB Hockmeyer Auditorium Address: One Medimmune Way, Gaithersburg, MD 20878 03 CBA科学研讨会注册 CBA诚挚邀请您参加2026年科学研讨会，了解学术界工业界最热门的科研以及监管动态，与各界专家交流合作，精彩内容，不容错过！ 2026 CBA科学研讨会注册链接和二维码：https://bit.ly/4xQa3KM。席位有限，欢迎大家尽快注册，锁定早鸟优惠票。 04 讲者介绍 Dr. Zhe Han is an internationally recognized geneticist and a Professor at the University of Maryland School of Medicine and Director of the Center for Precision Disease Modeling. He trained at Peking University, the University of Michigan, and UT Southwestern Medical Center. His laboratory pioneered gene replacement approaches for personalized Drosophila models of human genetic diseases, enabling mechanistic studies, variant interpretation, and therapeutic discovery. His research integrates disease modeling with AI-assisted treatment development and human cellular validation. He has published over 90 peer-reviewed articles and secured approximately $25 million in NIH funding. He serves as an NIH and European grant reviewer and an editor for Cell & Bioscience. Dr. Wenzhen Duan is Professor of Psychiatry and Neuroscience at Johns Hopkins University School of Medicine, Co-Director of the Division of Neurobiology, and Director of the Laboratory of Translational Neurobiology. She received her medical training from Shanxi Medical University in China in 1992 and Ph.D. from Peking Union Medical College in China in 1998. After postdoctoral training at the University of Kentucky and National Institute on Aging with Dr. Mark P. Mattson, she established the Translational Neurobiology Research Program at the Johns Hopkins University School of Medicine in 2004. The research in her laboratory centers on understanding the molecular mechanisms underlying neurodegenerative diseases with a focus on developing novel therapeutics and biomarkers for Huntington’s disease. Dr. Shengyun Fang is a Professor of Pharmacology and Physiology at the University of Maryland School of Medicine and an expert in the ubiquitin-proteasome system and ER-associated degradation. His research seeks to understand how disruption of these protein degradation pathways contributes to human disease and to translate these mechanistic insights into new therapies. To translate these discoveries toward therapeutic applications, his laboratory has pioneered systematic approaches to developing ER proteostasis-targeted therapeutics and developed several first-in-class compounds with potential applications in rare genetic diseases, including SOD1-ALS, VEXAS syndrome, α1-antitrypsin-associated liver disease, FENIB, INS mutation-associated neonatal diabetes, and familial neurohypophyseal dia Dr. Samuel Goldlust graduated from medical school at The Ohio State University, followed by residency at New York University Hospitals and fellowship at Memorial Sloan Kettering Cancer Center where he also served as Chief Fellow. In the 15 years to follow, he led the development of two multidisciplinary brain tumor centers and served as the principal investigator on 30 clinical trials for GBM and other CNS tumors. He joined Alexion in 2026 as the Global Clinical Lead in Rare Tumors with a focus upon CNS malignancies, with the goal of accelerating drug development through collaboration, innovative trial design and thoughtful preclinical discovery. Dr. Shaad E. Abedin is Chief Medical Officer of Quetzal Therapeutics, where he leads clinical development of QTX-2101, an investigational oral arsenic trioxide capsule for acute promyelocytic leukemia. He previously served as Senior Vice President and Head of Clinical Development at iTeos Therapeutics and held leadership roles at CARsgen and Immunocore, where he led clinical development of tebentafusp (KIMMTRAK), the first globally approved TCR bispecific therapy. At AstraZeneca/MedImmune, he contributed to early development of durvalumab and tremelimumab. He has authored more than 80 scientific works and patents and is board certified in internal medicine, hematology, and medical oncology. Dr. Frank Li is the 2018-2019 President of Chinese Biopharmaceutical Association (CBA， cba-usa.org) and a member of the board of directors. As the Chairman of CBA organizing committee, Dr. Li has successfully organized the 23rd Annual Conference in June 2018 with more than 800 attendees and famous Keynote Speakers from academia, regulatory authority, and industry including Drs. Lieping Chen (Yale University, Professor), Richard Pazdur (FDA, Center Director), Yongjun Liu (Sanofi, Global R&D Head), and Laurence Cooper (ZioPharm CEO). Dr. Li obtained his PhD degree in Molecular Medicine from Kyoto University, School of Medicine, Japan. He did medical residency in surgical departments in Beijing followed by clinical research training for his master’s degree in China-Japan Friendship Hospital and Peking Union Medical College in Beijing, China. Dr. Li has been working in the Biopharmaceutical industry for about 20 years including experiences in CROs and drug developers such as AstraZeneca and MedImmune. Dr. Li contributed to the development of FASENRA (an anti-IL5R antibody for Asthma) from Ph-2 to BLA regulatory defense leading to Regulatory approvals in world major markets. Dr. Li has been a volunteer to communities including CBA for many years. Now Dr. Li is the founder of BLA Regulatory, which provides consulting services in Regulatory Affairs to FDA regulated products including drugs and medical devices. Mr. John Higgins is Vice President, Technical Operations at Cartesian Therapeutics, with more than 24 years of experience developing, scaling, and commercializing biopharmaceutical products. His experience spans biologics, vaccines, cell therapies, ADCs, and novel adjuvants, with leadership roles at Kite Pharma, AstraZeneca, Novavax, and MedImmune. His expertise includes global manufacturing strategy, CMC, process development, technology transfer, validation, regulatory submissions, and commercialization. Biopharmaceutical R&D and regulatory executive with over 20 years of scientific and leadership experience spanning microbiology, cell biology, molecular biology, and immunology. Former CMC Reviewer at FDA’s Office of Biotechnology Products (OBP) and Vice President of Global Regulatory Compliance at Saifu Laboratories. Brings deep expertise in CMC development, product quality, and global regulatory strategy across biologics, cell and gene therapies, and ADCs. Combines rigorous scientific judgment with extensive knowledge of FDA, NMPA/CDE, and ICH frameworks, providing strategic leadership in resolving complex development challenges and advancing innovative therapeutics from early development through commercialization. Dr. Hongtao Yu is a Director Clinical Pharmacometrician at AstraZeneca. He completed his postdoctoral training at the University of Georgia, focusing on quantitative pharmacology and systems modeling in cardiorenal disease. At AstraZeneca, he applies clinical pharmacology, pharmacometrics, and model-informed drug development to support drug development across metabolic, cardiovascular, and renal indications. His expertise includes population PK, PK/PD, exposure–response analysis, quantitative systems pharmacology, and model-based meta-analysis. His work informs dose selection, trial design, and regulatory strategy from first-in-human studies through late-phase development. Dr. Yixing Hanis an interdisciplinary scientist specializing in computational human genetics, genomics, and precision health at NHGRI, NIH. Her work integrates statistical genetics, multi-omics, clinical genomics, and biomedical data science to investigate how genetic variation and biological context shape human health. She also leads computational research-program development, multidisciplinary studies, and trainee mentorship. Dr. Chunhong Liu is Associate Director at Hansoh Bio, where she leads the Translational Medicine team. Her work spans bioinformatics, AI pathology, de-novo design, organoid-based ex vivo study platforms, and clinical biomarker strategy for oncology and autoimmune disease drugs. She previously served as Senior Project Manager in Clinical Biomarker and Translational Medicine at Ascentage Pharma, directing PD and clinical biomarker strategy for hematologic oncology trials. Before moving to industry, Dr. Liu spent more than a decade in cancer, stem cell, immunology, and genomics research at Roswell Park Comprehensive Cancer Center, Johns Hopkins University School of Medicine, and the National Institutes of Health. She has published over 20 peer-reviewed papers, including a first-author study in Immunity. She earned her Ph.D. in Genetics from the Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, and completed graduate training in sequence analysis and genomics at Johns Hopkins University. Dr. Xin Wei is a clinical pharmacologist at Bristol Myers Squibb, where she supports late phase drug clinical development programs in hematology, oncology and autoimmune diseases. Prior to joining BMS, she worked at the U.S. Food and Drug Administration, contributing to clinical pharmacology research and regulatory science in areas including pharmacokinetics, immunogenicity, and drug development. She received her PhD in Pharmaceutical Sciences from the University of Nebraska Medical Center. Her professional interests include clinical pharmacology, model-informed drug development, regulatory science, and the translation of quantitative approaches into efficient drug development strategies. Dr. Angela Zeng is a Global Clinical Lead in the oncology department and Global Head of Asian ERG at AstraZeneca. She oversees clinical trials crossing Phase-1 to Phase-3 in the Enhertu-Breast/Gynecological and Imfinzi (Durvalumab) Gastrointestinal (GI) cancers programs, leading study design, execution, submission and other key activities of drug development and market authorization. Dr. Zeng has been a Physician representative in the leadership team and an active Clinical Reviewer on the Protocol Review Committee and ESR program. Before joining AZ, Dr. Zeng was a Study Physician in Ascentage Pharma, where she led Phase 1-2 studies and cross functional activities, and received outstanding annual awards. Prior to that, Dr. Zeng worked in Johns Hopkins Medical Institute as a research fellow/oncology faculty, focused on cancer immunotherapy. Dr. Zeng has been the Chair, organizer or invited speaker of multiple scientific symposiums or summits, organized online or in person international workshops/forums across US, EU, Canada and Asia countries. Currently she serves as the President and a Board member of CBA. Dr. Angela Zeng earned her MD/PhD from Fudan University (Formerly Shanghai Medical University) and practiced for over 10 years as an OB/Gyn surgeon. Dr. Qing Li is Head of Bioengineering and a core founding team member at PrimaLux BioMed, where she leads next-generation biologics drug development focused on improving therapeutic index and expanding the clinical benefits of biologics medicines for patients. With more than 15 years of experience in antibody therapeutics, Dr. Li has developed deep expertise in monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and enabling technology platforms. She holds multiple international patents and has published nearly 30 peer-reviewed scientific papers. Previously, Dr. Li served as Head of Biotherapeutics at Hansoh Bio, where she built research teams, established platform capabilities, and led multiple programs from discovery through PCC nomination and into clinical development. She also held key scientific roles at MedImmune and AstraZeneca, contributing to innovative biologics pipelines. Dr. Li currently serves as President-Elect and a board member of CBA-USA. She earned her bachelor’s degree from the University of Science and Technology of China, her Ph.D. from the University of Minnesota Twin Cities, and completed postdoctoral training at the University of Texas at Austin. 05 诚邀合作伙伴 CBA的合作伙伴将多次深度参与CBA举办的多个会议和重大活动，更有机会获得全方位、多维度的“多重展示”。为了进一步促进中美生物医药界的交流与前沿技术探讨，CBA现正式针对2026-2027年度系列旗舰盛会及核心交流平台开启赞助商招募： 2026-2027 年度旗舰盛会（重大品牌曝光机会） 2026年11月7日：聚焦罕见病的科学研讨会 —— 汇聚行业顶尖学者与研发力量，探讨前沿科学突破。 2027年2月：CBA新春Gala —— 凝聚生物医药华人社区的年度盛大庆典。 2027年4月：CBA职业发展论坛 —— 助力行业人才成长，为您精准链接企业与行业精英。 2027年6月12日：CBA年会 —— 年度最高规格行业峰会，洞悉全球宏观趋势与商业契机。持续性交流阵地（高频精准链接平台） CBA季度线上科学研讨会 —— 打破地域限制，每季度聚焦生命科学前沿热点，助您触达全球更广泛的专业受众群体。每月线下Happy Hour —— 为您提供轻松社交氛围下的高频曝光与面对面沟通机会。 CBA科创洞察平台（CBA Frontier Insights）—— 聚焦前沿科技与行业趋势的核心分享阵地，是彰显企业创新实力、提升行业影响力的绝佳舞台。未来全球生物制药和医疗保健行业面临着很多的挑战和机遇，CBA期待与各位新老合作伙伴，携手共赢，继续乘风破浪，砥砺前行，积极筹备，共同迎接新的机遇与挑战！欲获取更多独家赞助权益与详细信息，请与筹委会李清博士 (qing.li@cba-usa.org) 以及CBA微信公众号进行咨询联系。 06 关于CBA 美国华人生物医药科技协会（Chinese Biopharmaceutical Association，简称CBA，www.cba-usa.org）创建于1995年，是一家独立的、非官方的、非盈利的专业组织，是美国最大的中美专业技术协会之一。CBA总部位于美国首都华盛顿特区，CBA总部位于美国首都华盛顿特区，并且在波士顿，加拿大，中国设有分会。CBA约有10,000多名会员以及近百家公司机构会员，遍布世界各地，包括美国、中国、欧洲、加拿大、澳大利亚、新加坡和日本等国家和地区的专家学者和企业。 CBA始终秉承增进生物制药专业人士之间的交流与合作的使命，致力于推动人类生命健康行业发展，有效促进了不同国家和地区、尤其是中美之间的商业合作及伙伴关系，成为了人才与企业家的孵化器，建立了生物制药公司及研究机构合作成长和创新创业的环境。CBA多年来不间断地主办或与其他团体共同举办年会、专题讲习班、研讨会和社交联谊活动等，是专业人士分享专业知识和深入学习, 引领业界发展，建立人脉和寻求职业发展的平台。在CBA成员敬业奉献和赞助商多年来的持续支持中，CBA逐年发展壮大。 CBA大家庭成员正为进一步促进中美生物医药人才和项目的交流及开发和商业化创新性的医药产品而努力奋斗，内容涵盖了抗肿瘤新药和抗体，疫苗，核酸药，人类长寿健康，微生物分子诊断，基因治疗，细胞治疗，人工智能大数据和精准医疗，现代生物医药工厂，法律法规与监管条例，多类研究或产业发展的投资基金等等，以满足全球市场对多种疾病防治的临床需求，努力为服务于病人而多方位地贡献自己的力量，造福人类。在创新创业的队伍中，CBA的会长和会员中涌现出了一大批优秀的实干企业家和投资人，并取得了令人瞩目的成绩，同时为中美的科技交流，尤其生物医药方面的交流做了许多杰出的贡献。 07 CBA个人和企业会员注册 CBA诚邀您加入CBA大家庭！个人和企业会员注册二维码 08 赞助商和合作伙伴 CBA 诚挚感谢所有赞助商和合作伙伴的大力支持！

基因疗法临床研究

2026-10-20

·项目VIP

ESMO倒计时5天！中国研究占LBA三分之一、主席论坛5席——谁在定义下一个BD定价锚？

哈喽，各位项目VIP的朋友们～这里是你们的「项目VIP」。昨天聊的是"六张网"7万亿的工程项目盘子，今天切回【生物医药100天】频道——本栏目以100天为周期，连续追踪中国生物医药的行业动态、经营打法与融资经验。 10月23日-27日，2026年ESMO年会在西班牙马德里开幕。先甩一组硬核数据：本届ESMO约90项LBA（最新突破摘要）中，中国研究独占30项、占比三分之一；含金量最高的主席论坛LBA共12项，中国创新药独占5席（42%）。恒瑞80余项研究入选，康方近30项，信达新一代"IO+ADC"全家桶齐发…… 上期我们说过：签约只是起点，兑现才是本事。这期回答一个更锋利的问题——ESMO这5天，谁在定义下一个BD定价锚？一、行业动态：马德里"中国主场"的4张答卷【为您解读】把本届ESMO的中国看点拼成一张答卷—— 题型代表数据分量双抗2.0 康方依沃西1L胆道癌III期HARMONi-GI1：OS阳性，对比的是度伐利尤+化疗（已获批标准方案），入选主席论坛LBA，周俭院士10月25日报告从肺癌多瘤种扩张，直接对标全球标准疗法 ADC主力科伦博泰sac-TMT两项NSCLC III期LBA；恒瑞SHR-A1811（HER2低表达乳腺癌）、HER3 ADC HERON-Lung01；信达IBI343（CLDN18.2 ADC，全球首个申报NDA）3L胃癌III期LBA ADC后期的全球叙事由中国主导书写新一代IO 信达IBI363（PD-1/IL-2）更新1L NSCLC数据+首曝1L胃癌初步数据 "下一代IO基石"的全球竞速大会之外艾博生物×诺华：mRNA-TCE ABO2203，78亿美元授权、5.75亿美元首付款；阿斯利康20亿美元战略入股Summit押注依沃西联合ADC 数据读出前，MNC已提前扫货一句话：中国创新药从"国际会议参与者"升级为"国际会议贡献者"，首创数据的"首发权"正从MNC切换到中国药企。【项目场景】回顾节奏：6月ASCO好数据→9月BD大爆发（恒瑞26亿美元、迪哲6亿美元首付款）→10月ESMO。数据是BD的催化剂，ESMO就是下一波交易的"发令枪"。二、深挖一个典型事例：HARMONi-GI1凭什么进主席论坛？【为您解读】主席论坛是ESMO学术含金量最高的环节，入选标准是"改变全球临床实践"。依沃西这次答卷的含金量在三处细节： 1.对照组不是安慰剂、不是化疗，而是"度伐利尤单抗+化疗"——当前已获批的标准方案。头对头打标准疗法，赢了才算数。这是中国III期研究设计成熟度的标志：敢用全球最严的标尺量自己。 2.瘤种从肺癌扩到胆道癌。BTC是"癌王级"难治瘤种，一线治疗选择极少。依沃西此前已在WCLC公布HARMONi-2头对头OS超越K药，如今在消化系统再下一城，"PD-1/VEGF+化疗"正在从单点突破变成平台性打法。 3.OS终点，不是PFS。9月阿斯利康20亿美元入股Summit、押注依沃西联合ADC，本质上都是在为OS级别的确定性定价。金句：BD估值的锚，从来不是管线数量，而是"在标准方案头上拿OS"的能力。三、融资经验：MNC的钱和一级市场的钱，逻辑不一样【为您解读】看10月前后两路资金，打法完全不同—— 资金方动作定价逻辑跨国药企（MNC）艾博78亿美元授权、恒瑞26亿美元、荣昌RC148以6.5亿美元首付款授权艾伯维为"III期数据确定性+全球权益"付费，ESMO前后是谈判窗口一级市场联进生物超3亿元A轮、福沃药业新一轮（国资+美元混搭）、百趣生物近亿元B轮为"平台+数据密度"付费，看18个月内的临床里程碑给创始人的3条心得：大会就是融资节点。ESMO/ASCO数据读出前后2周，是BD和融资窗口期的心跳时刻——数据放榜前把BP、数据包、DD材料备齐，放榜当天就能接住MNC的电话。机会只留给提前6周备好资料的公司。 2.用"对照标准疗法"的思路讲融资故事。投资人现在自动过滤"me too+单臂数据"的叙事；你的研究设计敢不敢头对头，直接决定估值档位。 3.警惕"数据透支"。数据大会放榜后股价高开低走的案例不少——放榜前释放过度预期，放榜后没有增量信息，二级市场会用脚投票。预期管理也是经营能力。四、冷静剂：LBA是双向的——数据不及预期怎么办？【干货表格】LBA占三分之一，意味着"考试难度"也在提高。数据读出周，请备好这套预案—— 情景提前动作 OS优于对照第一时间启动BD/增发窗口，趁热锁定条款数据中性把亚组分析、生物标志物发现做成第二叙事不及预期冷静披露+明确的下一步开发计划，切忌沉默竞品同期"碾压" 回到差异化人群和联合疗法找生态位【项目场景】一句话：LBA是"迟到"才配得上的殊荣，也是放大镜——成绩和漏洞都会被放大3倍。做管线的VIP，要经得起高光，也要接得住质疑。五、生物医药100天 · 行动清单 1.Biotech/药企BD：10月23-27日排好"追会表"——主席论坛LBA（尤其10月25日HARMONi-GI1）必蹲，中国5席一个不落； 2.投资人：把上文数据地图当Checklist，数据落地后48小时内完成更新估值模型； 3.临床/注册同行：重点研究HARMONi-GI1的对照设计——"打标准疗法"将是下一轮注册临床的标配写法； 4.普通人：转发这篇给做创新药的朋友——数据周最好的姿势是：备好预案，敬畏数据。金句：考场只看数据，不看出身。做项目的VIP，也是做管线的VIP——数据敢头对头，估值才敢上一个台阶。下期预告：【生物医药100天】ESMO中国数据战报复盘：哪些数据兑现了预期，哪些改写了BD定价？ —— 做项目的VIP，做人生的VIP。这里是「项目VIP」，每天一篇，陪你把专业变成资产。觉得有用？点赞、在看、转发三连，是对原创最大的支持。数据来源：ESMO 2026大会官方议程及LBA列表；康方生物公告（2026-10）；信达生物新闻稿（2026-09-23）；美银证券ESMO 2026前瞻报告；MedSci 2026 ESMO LBA速览；公开研报纪要。本文不构成任何投资建议。往期回顾 3.5万亿、FIC占全球25%、百亿药企50家｜"十五五"规划落地，创新药拿到的是饭票还是考卷？生物医药企业能拿哪些政府资金？5类扶持政策+申报要点，别错过“白给”的钱生物医药项目的钱从哪来？研发—临床—上市各阶段资金地图，一张表看懂河北601个重点民间投资项目清单藏着什么机会肿瘤抗感染大适应症VS罕见病长周期慢病赛道生物医药股集体反弹，行业春天真的来了吗重磅新政！2026 北京高企认定 “报备即批准” 正式落地，企业不用再排队等批次这五类项目，再赚钱也轻易别碰一文读懂需要关注的“两重项目”清单6000亿投资机会

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01FF03	DB11714

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	美国	AstraZeneca UK Ltd.	2026-05-28
胃癌	欧盟	AstraZeneca AB	2026-03-16
胃癌	冰岛	AstraZeneca AB	2026-03-16
胃癌	列支敦士登	AstraZeneca AB	2026-03-16
胃癌	挪威	AstraZeneca AB	2026-03-16
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处腺癌	美国	AstraZeneca UK Ltd.	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15

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
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
微卫星稳定型实体瘤	临床3期	西班牙	AstraZeneca PLC	2024-12-30
晚期神经内分泌癌	临床3期	日本	AstraZeneca KK	2023-12-01
胃肠胰神经内分泌肿瘤	临床3期	日本	AstraZeneca KK	2023-12-01
小细胞癌	临床3期	日本	AstraZeneca KK	2023-12-01
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23

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临床结果

适应症

分期

评价

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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


NCT04392505 (DART, ESMO2026)	临床2期	非小细胞肺癌 III期 ctDNA	84	durvalumab+chemoradiotherapy	窪艱選齋簾積艱醖遞醖(製衊鑰繭積鬱餘遞鑰繭): HR = 12.2 (95.0% CI, 3.5 ~ 42.5), P-Value = < 0.0001 更多	积极	2026-10-23
				durvalumab+chemoradiotherapy (ctDNA detected in at least two consecutive surveillance samples)
NCT03528694 (POTOMAC, ESMO2026)	临床3期	非肌层浸润性膀胱肿瘤	435	Durvalumab+BCG (Induction and Maintenance)	齋顧鏇醖壓糧觸顧顧遞(構廠膚鏇廠齋膚選築獵) = 觸網窪積簾淵遞選糧膚選憲築繭願築選選齋淵 (憲範鬱膚襯衊壓製網積 ) 更多	积极	2026-10-23
				BCG (Induction and Maintenance)	齋顧鏇醖壓糧觸顧顧遞(構廠膚鏇廠齋膚選築獵) = 艱窪獵餘衊鑰壓齋觸襯選憲築繭願築選選齋淵 (憲範鬱膚襯衊壓製網積 ) 更多
NCT05128630 (DEDALUS, ESMO2026)	临床2期	非小细胞肺癌 III期	25	sequential chemo-durvalumab	鏇選糧蓋餘構觸淵構憲(餘憲膚簾膚鹽觸衊淵觸) = 遞餘窪壓顧遞糧遞鏇獵積鑰製憲願選齋選蓋窪 (觸壓鹹餘齋餘顧範選網, 10.7 ~ 18.6) 更多	积极	2026-10-23
				sequential chemo-durvalumab (patients who started maintenance without progression)	鏇選糧蓋餘構觸淵構憲(餘憲膚簾膚鹽觸衊淵觸) = 齋築獵構簾製醖窪齋簾積鑰製憲願選齋選蓋窪 (觸壓鹹餘齋餘顧範選網 ) 更多
NCT03732677 (NIAGARA, ESMO2026)	临床3期	肌层浸润性膀胱癌新辅助	1,063	Durvalumab + gemcitabine-cisplatin NAC + RC	願衊壓鹽鹹鏇膚鬱齋鑰(遞蓋廠築艱壓艱糧鏇願) = 鏇選衊簾餘艱淵壓夢遞廠膚襯膚餘齋顧顧艱鑰 (遞選壓壓鹹觸淵獵夢鏇 )	积极	2026-10-23
				Gemcitabine-cisplatin NAC + RC	願衊壓鹽鹹鏇膚鬱齋鑰(遞蓋廠築艱壓艱糧鏇願) = 蓋選範壓糧築觸鹹淵獵廠膚襯膚餘齋顧顧艱鑰 (遞選壓壓鹹觸淵獵夢鏇 )
NCT06859684 (HAlC-quad, ESMO2026)	临床2期	肝内胆管癌一线	25	Hepatic arterial infusion chemotherapy (HAIC) + durvalumab + lenvatinib	憲齋夢醖蓋鬱衊壓積顧(襯簾選蓋獵構蓋窪鬱蓋) = 積蓋鏇蓋醖憲願鏇繭艱夢積膚憲鬱鑰鑰鏇壓獵 (餘醖鏇鏇獵顧齋選窪窪 ) 更多	积极	2026-10-23
ESMO2026	N/A	胆道癌一线	963	cisplatin-gemcitabine-durvalumab (Very Early Chemotherapy Discontinuation (vECD))	壓衊衊網壓遞繭築簾衊(窪壓遞鏇繭簾觸齋積蓋) = 願淵構餘範糧鬱範範繭網壓鬱鏇廠鏇製積襯襯 (選網鑰積獵獵窪鏇夢網 ) 更多	积极	2026-10-23
				cisplatin-gemcitabine-durvalumab (Early Chemotherapy Discontinuation (ECD))	壓衊衊網壓遞繭築簾衊(窪壓遞鏇繭簾觸齋積蓋) = 憲繭鏇遞壓觸簾鬱積鏇網壓鬱鏇廠鏇製積襯襯 (選網鑰積獵獵窪鏇夢網 ) 更多
NCT03732677 (NIAGARA, ESMO2026)	临床3期	新辅助	165	Durvalumab + Gemcitabine-Cisplatin NAC and RC	窪鬱網築遞築憲築鬱憲(範憲網齋網醖願範鹽襯): HR = 0.52 (95.0% CI, 0.32 ~ 0.84) 更多	积极	2026-10-23
				Gemcitabine-Cisplatin NAC and RC
EUCTR2020-001050-22-DE (DOLPHIN, ESMO2026)	临床2期	小细胞肺癌	104	Durvalumab + RCT	醖襯觸憲淵鹽獵廠壓廠(衊網鹹衊遞顧襯糧鑰憲) = 鏇遞醖觸衊窪蓋糧膚憲鬱網壓鹽鬱構窪襯廠艱 (淵醖鬱鏇築積鬱鏇網餘 ) 更多	积极	2026-10-23
				RCT alone	醖襯觸憲淵鹽獵廠壓廠(鏇鏇餘鬱淵觸鹽網鹽鹹) = 糧壓範顧構膚糧夢選餘繭鹹鑰鬱鑰齋壓膚獵齋 (憲獵憲窪選憲積醖艱積 ) 更多
NCT07012798 (DB-Hero, ESMO2026)	临床2期	局部晚期肝细胞癌	30	durvalumabbevacizumabery infusion chemotherapy (HAIC-FOLFOX) + durvalumabbevacizumab + durvalumabbevacizumab (Sequential stereotactic body radiotherapy (SBRT))	鏇繭獵選鏇簾膚膚選襯(鑰醖遞獵襯膚構蓋夢鹽) = 鏇鬱醖鹽鬱範窪網艱網糧繭廠餘願鏇鹹餘膚淵 (顧窪鏇製齋鏇觸淵衊觸 )	积极	2026-10-23
ESMO2026	N/A	胆道癌一线	34	Durvalumab plus gemcitabine/platinum	簾構鑰構夢築襯鑰膚選(鏇願顧餘憲鏇糧蓋衊窪) = 鹽選製築觸築夢壓壓蓋網淵淵齋簾膚壓衊觸選 (襯獵網獵廠鑰憲淵繭遞 ) 更多	积极	2026-10-23