A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

开始日期2025-12-01

申办/合作机构

基石药业

NCT07033689

/ Not yet recruiting早期临床1期

Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

开始日期2025-12-01

申办/合作机构

Sonire Therapeutics Inc

NCT07020065

/ Not yet recruiting临床2期IIT

Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% A Multicentre Randomized Open-label Phase II Trial

Metastatic non-small cell lung cancer is often treated with a combination of chemotherapy and immunotherapy. In patients over the age of 70, some are already in poor health and frail, requiring assistance with daily activities, for example. Older and/or frail individuals often do not tolerate standard-dose chemotherapy well, and their risk of side effects is higher than that of younger patients.
For this reason, the SAKK 18/24 study is investigating how effective and safe chemotherapy is in patients over 70 years of age when the chemotherapy drugs are administered at lower doses than usual. The aim of the study is to find a potentially effective and well-tolerated treatment for older people with metastatic non-small cell lung cancer.

开始日期2025-11-01

申办/合作机构

Swiss Group for Clinical Cancer Research

100 项与吉西他滨相关的临床结果

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100 项与吉西他滨相关的转化医学

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100 项与吉西他滨相关的专利（医药）

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26,323

项与吉西他滨相关的文献（医药）

2026-03-01·BIOMATERIALS

Temperature-activated in situ hydrogel augments tumor treatment

Article

作者: Yang, Haojian ; Yu, Qianqian ; Yang, Ting ; Zhang, Cuiyun ; Wu, Qi ; Liu, Jihong ; Liang, Jiahui ; Wang, Qi ; Lin, Jiangtao ; Shi, Yiqi ; Zhu, Wei-Hong ; Yao, Chenxing ; Xu, Shiyun

In situ gels with tumor-targeted therapy often struggle with precise spatiotemporal drug release, compromising their efficacy in complex and heterogenous tumors. Here, we present a temperature-activated in situ hydrogel (PTT-Br@mPEG-PLGA and Gem@TCM-TK-PEG in chitosan and PF127 gel, denoted as PP + GC gel. Therein, the photothermal compound PTT-Br is fully named 6-bromo-1-ethyl-2-(2-(6-hydroxy-2,3-dihydro-1H-xanthen-4-yl)vinyl)quinolin-1-ium, while the reactive oxygen species (ROS)-responsive polymer TCM-TK-PEG is fully named tricyano methylene pyridine-thioketal-polyethylene glycol.) with the physiological temperature/photothermal/ROS-responsive drug store and release, thereby maximizing treatment outcomes. After intratumoral injection, PP + GC gel undergoes physiological temperature (37 °C)-responsive sol-gel phase transition, forming stable drug depot for enhanced tumor retention. Upon 635 nm laser irradiation, loaded photothermal agent converts light energy into heat (∼45 °C), triggering photothermal-responsive gel-sol phase transition for actively controlling encapsulated ROS-responsive therapeutic agents release, coupled with photothermal therapy. Subsequently, high levels of ROS in tumor cells disrupt the structure of ROS-responsive therapeutic agents, switching on the chemotherapeutic drug gemcitabine release and further stimulating immune response. Remarkably, laser irradiation of multiple short-duration induces a stronger immune response than that of single long-duration, thus achieving superior treatment outcomes. Benefiting from the smart control of photothermal therapy, chemotherapy, and immunotherapy, active PP + GC gel exhibits a tumor inhibition rate of approximately 82.25 % in melanoma-bearing mouse models, demonstrating significant antitumor efficacy while maintaining excellent biosafety.

2026-02-01·Biomaterials advances

Sustained and localized delivery of gemcitabine using chitosan-PVA-TPP polymeric implant enhances antitumor efficacy and delays surgical relapse in pancreatic cancer

Article

作者: Saha, Panchali ; Valvi, Snehal K ; De, Abhijit ; Thorat, Rahul ; Kumari, Archana ; Bandyopadhyaya, Rajdip ; Mal, Arijit ; Chilakapati, Murali Krishna ; Patel, Parikshit

Gemcitabine (GEM), one of the first lines of therapy in pancreatic cancer (PC) patients, has certain limitations, such as, low plasma half-life, limited bioavailability and treatment index. To address these issues, a localized and sustained delivery approach is undertaken, where we have developed a biodegradable polymeric film implant, by solvent casting method, using chitosan, polyvinyl alcohol (PVA), and sodium tripolyphosphate (TPP). Incorporating PVA and crosslinker TPP with chitosan enhances the mechanical strength of the chitosan film, evident from reduction of elastic modulus from 18.51 to 0.19 MPa. Under in vitro conditions, the film gradually releases GEM, exhibiting increased cell-killing capabilities in both 2D and 3D cell models and enhanced efficacy against GEM-resistant PC cells. Delivery through implant induces alteration of the lipid content of cells and significantly (p < 0.0001) enhances DNA double-strand break and antiproliferative properties. Furthermore, antitumor efficacy of GEM-loaded film (GEM-film) in pre-clinical settings significantly (p < 0.05) impairs tumor growth in advanced subcutaneous models and mitigates therapy resistance. GEM-film implants have proven ~7 times more effective in orthotopic models and have also delayed surgical relapse in PC mice models. Our study demonstrates that the delivery of GEM using the polymeric composite film is advantageous over that of free GEM in a pre-clinical context.

2026-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Pi Ji Pills reshape the pancreatic cancer immune microenvironment and enhance the efficacy of gemcitabine through dual mechanisms of PI3K/AKT pathway blockade and NETs inhibition

Article

作者: Li, Yi ; Liu, Fudong ; Jiang, Xiaochen ; Pang, Bo ; Shen, Qian ; Lin, Hai ; Zhang, Chuanlong

ETHNOPHARMACOLOGICAL RELEVANCE:

Pancreatic cancer presents a significant challenge in clinical treatment. Pi Ji Pills (PJP) is a compound formula made up of seven traditional Chinese medicinal herbs. It has demonstrated positive clinical outcomes in the treatment of pancreatic cancer, and its potential pharmacological mechanisms warrant further investigation.

AIM OF THE STUDY:

This study aimed to identify the possible mechanisms by which PJP inhibits pancreatic cancer, followed by experimental verification and more profound exploration.

MATERIALS AND METHODS:

An in vivo pancreatic cancer xenograft model was established to observe the effect and safety of PJP on tumor growth. The SW1990 cells were cultured to investigate the intervention effects of PJP-containing serum on the malignant biological behavior of pancreatic cancer cells. Subsequently, network pharmacology analysis was employed to explore the potential mechanisms. Furthermore, both in vivo and in vitro experiments were conducted to validate the core pathways and targets. An in-depth exploration was performed, with a focus on the role of neutrophil extracellular traps (NETs) in the inhibition of pancreatic cancer by PJP.

RESULTS:

PJP inhibits tumor growth, and its combination with gemcitabine exhibits enhanced inhibitory effects, partially alleviating immune suppression. PJP-containing serum was found to inhibit the malignant biological behavior of SW1990 cells. naringenin, atractylenolide I, isoalantolactone, curcumenol, parthenolide, and arglabin are the main active components of PJP. PJP inhibits PI3K/AKT pathway, key to its anti-pancreatic cancer effects. Additionally, PJP's treatment inhibited SW1990 cell proliferation indenpence of reducing IL-8 and downregulating NETs-related protein expression in the co-culture system.

CONCLUSIONS:

PJP combats pancreatic cancer and enhances gemcitabine efficacy by remodeling the immunosuppressive tumor microenvironment. This anticancer effect may be attributed to a dual-target mechanism involving suppression of the PI3K/AKT pathway and regulation of NETs formation in the tumor microenvironment.

2,267

项与吉西他滨相关的新闻（医药）

2025-10-14

·阿斯利康中国

阿斯利康携四项重磅研究首发数据亮相欧洲肿瘤内科学会（ESMO）年会，进一步彰显重新定义癌症治疗的雄心

● DESTINY-Breast11与DESTINY-Breast05两项研究入选主席研讨会（Presidential Symposium），凸显德曲妥珠单抗在治疗HER2阳性早期乳腺癌中的潜在价值 ● TROPION-Breast02研究数据将展示德达博妥单抗在转移性三阴性乳腺癌这一最具侵袭性的乳腺癌分型中的治疗潜力 ● POTOMAC研究的无病生存期数据与MATTERHORN研究的生存期数据将展示度伐利尤单抗在早期膀胱癌与胃癌治疗中的获益重磅发布 2025年10月14日，上海——阿斯利康将于2025年10月17日至21日召开的欧洲肿瘤内科学会（ESMO）年会上，凭借行业领先的多样化产品与管线布局的全新研究数据，进一步彰显其重新定义癌症治疗格局的雄心壮志。本次大会上，阿斯利康将公布逾95项摘要，涵盖9款已获得批准药物及9款潜在新药，包括2项入选重磅主席研讨会（Presidential Symposium）的摘要以及26项口头报告。其中主要亮点包括： DESTINY-Breast11：评估德曲妥珠单抗序贯THP方案（紫杉醇、曲妥珠单抗及帕妥珠单抗）用于高风险HER2阳性早期乳腺癌新辅助治疗的III期临床研究（主席研讨会1，摘要#291O）。 DESTINY-Breast05：评估德曲妥珠单抗用于HER2阳性早期乳腺癌（新辅助治疗后存在残留浸润病灶并具有高复发风险）的III期临床研究（主席研讨会1，摘要#LBA1）。 TROPION-Breast02：评估德达博妥单抗用于一线治疗无法接受免疫治疗的局部复发性不可手术或转移性三阴性乳腺癌（TNBC）患者的III期临床研究（优选论文摘要#LBA21）。 POTOMAC：评估度伐利尤单抗联合卡介苗（BCG）诱导与维持治疗，用于高危非肌层浸润性膀胱癌（NMIBC）患者的III期临床研究（优选论文摘要#LBA108）。 MATTERHORN：公布III期临床研究的最终总生存期（OS）结果，评估度伐利尤单抗联合FLOT化疗作为可切除的早期和局部晚期的胃和胃⻝管结合部腺癌（GEJ）患者围手术期治疗中的临床获益（优选论文摘要#LBA81）。高书璨(Susan Galbraith) 阿斯利康全球执行副总裁全球肿瘤研发负责人我们正加速推进多元创新疗法管线，以变革乳腺癌患者的治疗格局。在本届ESMO大会上，我们将公布TROPION-Breast02、DESTINY-Breast11和DESTINY-Breast05研究的数据和重要进展。同时，我们也将展示新一代潜在抗肿瘤新药的数据，包括saruparib联合新型激素疗法用于前列腺癌领域，靶向叶酸受体的抗体偶联药物torvu-sam用于卵巢癌领域，以及rilvegostomig用于在非小细胞肺癌领域。 Dave Fredrickson 阿斯利康全球执行副总裁肿瘤业务负责人我们业界领先的肿瘤产品组合在本次ESMO持续展现强劲势头，首次公布了四项关键研究的数据。其中，不仅有德曲妥珠单抗和德达博妥单抗在乳腺癌领域的重大进展，度伐利尤单抗的POTOMAC试验结果也证明了免疫疗法为早期膀胱癌治疗带来的益处，进而阐释我们的策略——将前沿治疗引入癌症早期这一患者最能够获益的阶段。其它亮点包括： FONTANA：评估靶向叶酸受体α（FRα）的抗体药物偶联物AZD5335用于铂耐药复发性卵巢癌患者的I/IIa期首次人体临床试验（简短口头报告摘要#1065MO）。 PETRANHA：评估saruparib联合雄激素受体通路抑制剂用于治疗转移性前列腺癌患者的I/II期临床研究（简短口头报告摘要#2384MO）。 ARTEMIDE-01：评估rilvegostomig用于检查点抑制剂初治的转移性非小细胞肺癌（NSCLC）患者的I/II期临床研究（简短口头报告摘要#1853MO）。 FLAURA2：在奥希替尼合化疗治疗晚期EGFR突变NSCLC患者的FLAURA2 III期临床研究中存在不良预后因素患者的探索性OS分析（优选论文摘要#LBA77）。 CAPItello-281：卡匹色替联合阿比特龙和雄激素剥夺疗法（ADT）用于PTEN缺陷的新发转移性激素敏感性前列腺癌（mHSPC）的III期临床研究（优选论文摘要#2383O）。 TROPION-PanTumor03：评估德达博妥单抗联合rilvegostomig治疗局晚期或转移性尿路上皮癌（a/mUC）患者的疗效： II期TROPION-PanTumor03研究结果结果（简短口头报告摘要 #3072MO）。 BEGONIA：德达博妥单抗联合度伐利尤单抗用于既往未经治疗的不可切除、局部晚期或转移性三阴性乳腺癌（TNBC）患者的BEGONIA Ib/II期试验最终结果（口头报告摘要#555MO）。阿斯利康与第⼀三共联合开发和商业化德曲妥珠单抗与德达博妥单抗；与默沙东（默沙东是美国新泽⻄州罗威市默克公司的公司商号）联合开发和商业化奥拉帕利；与和黄医药合作开发和商业化赛沃替尼。Rilvegostomig是一种靶向PD-1和TIGIT的双特异性抗体，其中TIGIT部分源自Compugen公司临床阶段的抗TIGIT抗体COM902。阿斯利康在2025年 ESMO年会期间的重要演讲1 主要作者摘要标题报告详情(CEST) 抗体偶联药物 Harbeck, N DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC). Abstract #291O Presidential 1 18 October 2025 4:30 PM Geyer, C Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05. Abstract #LBA1 Presidential 1 18 October 2025 4:52 PM Dent, R. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase 3 TROPION-Breast02 trial. Abstract #LBA21 Proffered Paper Session 19 October 2025 9:25 AM Loibl, S Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analysis of DESTINY-Breast09 in key subgroups of interest. Abstract #LBA18 Proffered Paper Session 19 October 2025 8:30 AM Rha, SY Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase 2 TROPION-PanTumor03 study. Abstract #3072MO Mini Oral Session 17 October 2025 4:10 PM Oaknin, A First-in-human study of AZD5335, a folate receptor α (FRα)-targeted antibody-drug conjugate, in patients with platinum-resistant recurrent ovarian cancer. Abstract #1065MO Mini Oral Session 19 October 2025 10:53 AM Schmid, P Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment (tx) for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Final results from the phase 1b/2 BEGONIA study. Abstract #555MO Mini Oral Session 20 October 2025 10:50 AM Raghav, K Trastuzumab deruxtecan (T DXd) in patients (pts) with HER2-positive (HER2+) metastatic colorectal cancer (mCRC): Final analysis of DESTINY-CRC02, a randomized, phase 2 trial. Abstract #737P Poster Session Peng, Z Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who received prior anti-HER2 treatment (Tx) other than / in addition to trastuzumab in DESTINY-Gastric06 (DG-06) Abstract #2105P Poster Session Shen, L Risk of hepatitis B virus reactivation (HBVr) in patients (pts) with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06 (DG-06) trial. Abstract #2175P Poster Session Pietrantonio, F Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) plus paclitaxel (PTX) in second-line (2L) treatment of patients (pts) with HER2+ unresectable/metastatic gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJA): Additional data from DESTINY-Gastric04 (DG-04). Abstract #2099P Poster Session Makker, V Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) Part 1 final analysis. Abstract #957P Poster Session Lee, J-Y Trastuzumab deruxtecan (T-DXd) in pretreated patients (pts) with HER2-expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 (DP-02) Part 1. Abstract #145P Poster Session 免疫肿瘤学 Tabernero, J MATTERHORN Phase III trial of Imfinzi (durvalumab) perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. Abstract #LBA81 Proffered Paper Session 17 October 2025 2:00 PM De Santis, M Durvalumab (D) in Combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, High-risk Non-muscle-invasive Bladder Cancer (NMIBC): Results from the Phase 3, Open-label, Randomised POTOMAC Trial. Abstract #LBA108 Proffered Paper Session 17 October 2025 2:10 PM Larkin, J First results from RAMPART: An international phase 3 randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL. Abstract #LBA93 Proffered Paper Session 18 October 2025 9:20 AM Aghajanian, C Durvalumab + paclitaxel/carboplatin + bevacizumab followed by durvalumab, bevacizumab + olaparib maintenance in patients with newly diagnosed non-tBRCA-mutated advanced ovarian cancer: final overall survival from DUO-O/ENGOT-ov46/GOG-3025. Abstract #LBA44 Mini Oral Session 19 October 2025 11:31 AM Goss, G CCTG BR.31: Adjuvant durvalumab (D) in resected non-small-cell lung cancer (NSCLC): final overall survival (OS) and minimal residual disease (MRD) analyses. Abstract #LBA68 Mini Oral Session 20 October 2025 3:20 PM Heymach, J Association of radiomic features ± on-treatment ctDNA detection with treatment outcomes in patients with resectable NSCLC: exploratory analyses from AEGEAN。 Abstract #LBA70 Mini Oral Session 20 October 2025 3:50 PM Wermke, M Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study. Abstract #2757O Proffered Paper Session 18 October 2025 8:30 AM Loibl, S Durvalumab in Combination with Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC) – Long-term Analysis from the GeparNuevo Trial. Abstract #292MO Mini Oral Session 19 October 2025 10:15 AM Van der Heijden, M Health-related quality of life (HRQoL) from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). Abstract #3069MO Mini Oral Session 17 October 2025 4:00 PM Sangro, B Pooled efficacy and safety outcomes with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the combined China extension and global cohorts in the Phase 3 HIMALAYA study. Abstract #1494P Poster Session Westin, S Durvalumab plus carboplatin/paclitaxel followed by durvalumab for endometrial cancer: Tumour mutational burden-high subpopulation efficacy analyses from the DUO-E trial. Abstract #1117P Poster Session Leal, TA Global quantitative assessment of multidisciplinary team (MDT) care in early-stage NSCLC. Abstract #1794P Poster Session Reck, M Neoadjuvant durvalumab (D) + chemotherapy (CT) followed by either surgery (Sx) and adjuvant D or CRT and consolidation D in patients (pts) with resectable or borderline resectable stage IIB–IIIB NSCLC: interim analysis (IA) of the phase 2 MDT-BRIDGE study. Abstract #LBA65 Proffered Paper Session 18 October 2025 9:15 AM Maruki, Y CELEBRATE Study (JCOG2107E): A Multicenter, Open-label, Phase III Trial of Etoposide, Carboplatin, and Durvalumab in First-line Treatment of Unresectable or Recurrent Digestive NEC. Abstract #1734TiP Poster Session Oudard, S A phase IIIb, open-label, single-arm, global study of perioperative durvalumab (D) with neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or gemcitabine/cisplatin (gem/cis) in patients with muscle-invasive bladder cancer (MIBC) (NIAGARA-2). Abstract #3133eTiP ePoster Session 双特异性抗体 Chul Cho, B Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific Antibody, for Checkpoint Inhibitor (CPI)-Naïve Metastatic Non-Small-Cell Lung Cancer (mNSCLC): ARTEMIDE-01. Abstract #1853MO Mini Oral Session 20 October 2025 10:25 AM Slomovitz, BM A randomized Phase 3 study of first-line (1L) trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2-expressing, mismatch repair-proficient (pMMR), primary advanced or recurrent endometrial cancer (EC): DESTINY-Endometrial01/GOG-3098/ENGOT-EN24. Abstract #1223TiP Poster Session Naidoo, J ARTEMIDE-Lung04: A Phase 3, randomised, double-blind, global study of rilvegostomig or pembrolizumab monotherapy as first-line (1L) treatment for patients with metastatic non-small cell lung cancer (mNSCLC) and programmed cell death ligand-1 (PD-L1) expression ≥50%. Abstract #2025TiP Poster Session 肿瘤驱动因子和耐药性 Jänne, PA FLAURA2: exploratory overall survival (OS) analysis in patients (pts) with poor prognostic factors treated with osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) as first-line (1L) treatment for EGFR-mutated (EGFRm) advanced NSCLC. Abstract #LBA77 Proffered Paper Session 17 October 2025 4:56 PM Mayer, E Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). Abstract #486MO Mini Oral Session 20 October 2025 10:25 AM Arriola, E Molecular residual disease (MRD) analysis from the LAURA study of osimertinib (osi) in unresectable (UR) stage III EGFR-mutated (EGFRm) NSCLC. Abstract #1817MO Mini Oral Session 20 October 2025 2:55 PM Park, YH Visual symptom questionnaire results from SERENA-6, a Phase 3 study of switch to camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) at emergence of ESR1m during first-line (1L) therapy for patients (pts) with HR+/HER2- advanced breast cancer (ABC). Abstract #528P Poster Session Chu, Q SAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osi. Abstract #1955P Poster Session Rotow, J MET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Interim analysis of a global real world (rw) study. Abstract #1967P Poster Session Yu, Y ctDNA analysis in phase 3 SACHI trial: Savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI). Abstract #1954P Poster Session DNA损伤应答 Azad, AA First interim efficacy analysis of the Phase 1/2 PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). Abstract #2384MO Mini Oral Session 17 October 2025 2:35 PM Fizazi, K A Phase 3 study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Abstract #2383O Proffered Paper Session 19 October 2025 11:19 AM Rugo, HS Capivasertib with fulvestrant as first- and second-line endocrine therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the Phase 3 CAPItello-291 trial. Abstract #526P Poster Session Gao, Q Final overall survival (OS) analysis of L-MOCA: olaparib maintenance monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC). Abstract #1090P Poster Session AI驱动的临床试验 Gonuguntla, HK Real-World Validation of AI-defined Lung Nodule Malignancy Score (qXR-LNMS) in Predicting Risk of Lung Cancer: Interim results from Phase 2. Abstract #2978P Poster Session 1阿斯利康在2025年ESMO年会将公布逾90个摘要，涵盖其产品和管线中的分子药物。关于阿斯利康肿瘤领域的研究阿斯利康正引领着肿瘤领域的⼀场⾰命，致⼒提供多元化的肿瘤治疗⽅案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变⽣命的药物。阿斯利康专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已经建⽴了⾏业领先的多元化的产品组合和管线，持续推动医疗实践变⾰，改变患者体验。阿斯利康以期重新定义癌症治疗并在未来攻克癌症。关于阿斯利康阿斯利康（LSE/STO/Nasdaq: AZN）是⼀家科学⾄上的全球⽣物制药企业，专注于研发、⽣产及营销处⽅类药品，重点关注肿瘤、罕⻅病以及包括⼼⾎管肾脏及代谢、呼吸及免疫在内的⽣物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。关于阿斯利康中国阿斯利康⾃1993年进⼊中国以来，专注中国患者需求最迫切的治疗领域，包括肿瘤、⼼⾎管、肾脏、代谢、呼吸、消化、罕⻅病、疫苗抗体及⾃体免疫等，已将40多款创新药物带到中国。阿斯利康中国总部位于上海，并在上海和北京设⽴全球战略研发中⼼，在北京、⼴州、杭州、成都、⻘岛设⽴区域总部，在⽆锡、泰州、⻘岛建⽴全球⽣产供应基地，向全球70多个市场输送优质创新药品。声明：本文研究中涉及的多种药品用法尚未在中国获批适应症，阿斯利康不推荐任何未被批准的药品使用。内容来源：新闻稿（内部审批号：CN-169484）

临床3期临床成功免疫疗法临床结果

2025-10-14

·PRNewswire

iOnctura debuts cambritaxestat (IOA-28G) clinical data in patients with pancreatic cancer at ESMO

Cambritaxestat, the first autotaxin (ATX) inhibitor to be investigated in cancer patients, meets its primary endpoint in a study to assess safety and anti- tumour responses in patients with metastatic pancreatic cancer Combining cambritaxestat with gemcitabine/nab-paclitaxel (GnP) was tolerable and associated with anti-tumor responses Cambritaxestat administration combined with GnP demonstrated reduction in pharmacodynamic markers associated with fibrosis, immune regulation and tumor progression GENEVA and AMSTERDAM and CAMBRIDGE, Mass., Oct. 14, 2025 /PRNewswire/ -- iOnctura, a clinical-stage precision oncology company focused on neglected and hard-to-treat cancers, today announces the Phase Ib study investigating oral autotaxin (ATX) inhibitor, cambritaxestat (IOA-289), has met the primary endpoint: demonstrating safety, tolerability and anti-tumor responses, in combination with standard-of-care chemotherapy, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). These data are being presented as a poster at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.1 Lead investigator, Davide Melisi, M.D., Ph.D, Associate Professor of Medical Oncology, and Director of the Digestive Molecular and Clinical Oncology Research Unit, University of Verona, and Investigational Cancer Therapeutics Clinical Unit at the University Hospital of Verona, Verona, Italy said, "These early findings with cambritaxestat are encouraging. Clinical activity alongside a manageable safety profile is particularly meaningful in a disease as aggressive and fibrotic as metastatic pancreatic cancer. These findings warrant continued scientific exploration in autotaxin inhibition." The Phase Ib dose escalation study, AION-02 (NCT05586516) evaluated cambritaxestat in combination with standard-of-care chemotherapy GnP in patients with previously untreated mPDAC. Sixteen patients received cambritaxestat orally, twice daily at doses of 100 mg (n=4), 200 mg (n=4), 400 mg (n=5) and 800 mg (n=3). GnP was administered by IV infusion, weekly for three weeks of a four-week cycle. The results show no dose-limiting toxicities, and no treatment-emergent adverse events (TEAE) leading to drug discontinuation or dose modification. Pharmacodynamic analysis showed a dose dependent reduction in the ATX-dependent plasma lipid LPA C18:2 over 24 hours supporting cambritaxestat's on-target effects. Patients in the higher-dose cohorts had consistent and durable reductions of the tumor marker CA19-9. These changes were associated with radiographic responses and survival. Dr. Michael Lahn, Chief Medical Officer at iOnctura said, "These data reinforce the therapeutic promise of targeting the autotaxin pathway to address the complex biology of pancreatic cancer, and potentially other tumors with high expression of autotaxin and its associated signaling. As we advance development, we remain focused on unlocking the potential of cambritaxestat to improve outcomes for patients facing some of the most challenging and hard-to-treat cancers." Cambritaxestat is the first autotaxin inhibitor to be investigated in cancer patients and is being developed as a first-in-class therapy across multiple cancer indications. This study was co-funded by the European Union and recruited patients in Italy and the United Kingdom. For more information contact: iOnctura Corporate Press Office: [email protected] About iOnctura iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura is headquartered in Amsterdam, The Netherlands with subsidiaries located in Geneva, Switzerland and Cambridge, MA, USA. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture. About cambritaxestat Cambritaxestat is an orally administered autotaxin inhibitor being developed for the treatment of highly fibrotic cancers, including metastatic pancreatic cancer. By targeting the autotaxin pathway, cambritaxestat offers a novel three-pronged approach—directly inhibiting tumor growth, stimulating immune effector cells, and reducing fibrosis to enhance drug and immune cell access to the tumor. Cambritaxestat received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA), in March 2024. This study was co-funded by the European Union. 1 ESMO Abstract #2227P: A Quinzii et al. Safety and clinical efficacy of cambritaxestat (IOA-289), a novel autotaxin inhibitor, plus gemcitabine and nab-paclitaxel (GnP) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Abstract available, 13 October 2025. Poster presented at the European Society of Medical Oncology (ESMO) congress, 19 October 2025. Logo: SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果孤儿药ASCO会议临床2期

2025-10-14

·Firstwordpharma

Astellas' Vyloy misses OS goal in Phase II pancreatic cancer study

Astellas on Tuesday said its CLDN18.2-directed antibody Vyloy (zolbetuximab), when combined with chemotherapy, failed to show a survival benefit in treatment-naïve patients with metastatic pancreatic adenocarcinoma at the final analysis of a mid-stage study. The Phase II GLEAM trial assessed first-line Vyloy plus gemcitabine and nab-paclitaxel in 393 adults whose tumours expressed CLDN18.2 in at least 75% of cells. Astellas said the Vyloy combination fell short on the primary endpoint of overall survival (OS), although it maintained a favourable safety profile. The company indicated that it will conduct a comprehensive evaluation of the data and collaborate with investigators on disseminating additional findings, including secondary endpoints and subgroup analyses. Vyloy remains the only approved therapy for CLDN18.2-positive HER2-negative gastric or gastroesophageal junction cancer across multiple markets, including the US, the EU, Japan and China. Earlier this year, the Japanese drugmaker said Vyloy sales had “expanded beyond expectations,” generating JPY 12.2 billion ($85 million) in fiscal 2024. Meanwhile, in May, Astellas bagged ex-China rights to Evopoint Biosciences’ investigational antibody-drug conjugate (ADC) targeting CLDN18.2, dubbed XNW27011, which is currently being investigated in gastric, gastroesophageal and pancreatic cancers.

抗体药物偶联物临床结果临床2期上市批准临床1期

100 项与吉西他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02368	吉西他滨	L01BC05	DB00441

研发状态

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
胰腺癌	临床3期	-	RenovoRx, Inc.	2023-06-01
转移性胰腺导管腺癌	临床3期	澳大利亚	Panbela Therapeutics, Inc.	2022-08-04
局部晚期胰腺腺癌	临床3期	美国	RenovoRx, Inc.	2018-03-12
局部晚期胰腺腺癌	临床3期	比利时	RenovoRx, Inc.	2018-03-12
晚期鳞状细胞肺癌	临床3期	美国	Sanofi	2010-03-01
晚期鳞状细胞肺癌	临床3期	比利时	Sanofi	2010-03-01
晚期鳞状细胞肺癌	临床3期	加拿大	Sanofi	2010-03-01
晚期鳞状细胞肺癌	临床3期	法国	Sanofi	2010-03-01
晚期鳞状细胞肺癌	临床3期	德国	Sanofi	2010-03-01
晚期鳞状细胞肺癌	临床3期	匈牙利	Sanofi	2010-03-01

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临床结果

适应症

分期

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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


ASCO2025	N/A	晚期胆道癌一线	45	Cisplatin, Gemcitabine, Durvalumab	製夢範壓製獵艱淵築構(製夢獵淵壓糧觸艱壓夢) = 醖願獵糧膚醖範糧觸襯廠憲衊膚築餘衊憲範範 (襯鑰淵顧範醖糧蓋餘齋 ) 更多	积极	2025-05-30
NCT02807181 (SIRCCA, CTgov)	临床2/3期	不可切除的肝内胆管癌	89	gemcitabine+Cisplatin (Chemotherapy (Cisplatin-Gemcitabine))	鬱製壓膚憲壓網壓顧築(糧窪廠夢窪膚窪膚鏇願) = 構齋襯艱鏇網鏇築膚顧淵製鹽壓願觸顧齋網觸 (淵憲願鬱網鬱鑰鑰構壓, 觸鏇衊壓簾鏇夢鬱鬱夢 ~ 壓淵夢繭願選淵構築鏇) 更多	-	2025-05-09
NCT02807181 (SIRCCA, CTgov)	临床2/3期	不可切除的肝内胆管癌	89	Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)+gemcitabine+Cisplatin (Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine))	鬱製壓膚憲壓網壓顧築(糧窪廠夢窪膚窪膚鏇願) = 構艱鹽築構鑰鬱獵淵廠淵製鹽壓願觸顧齋網觸 (淵憲願鬱網鬱鑰鑰構壓, 選選齋繭淵膚獵範積簾 ~ 範遞範鹹鑰襯簾鬱衊醖) 更多	-	2025-05-09
NCT04602078 (AUREA \| SOGUG-AUREA, CTgov)	临床2期	膀胱尿路上皮癌 \| 局部晚期尿路上皮癌 \| 转移性尿路上皮癌	82	Cisplatin 70 mg/m2+Gemcitabine 1000 mg/m2+Atezolizumab 1200 mg/m2	鏇襯壓積膚範餘獵鑰艱 = 願願構遞壓觸鹽憲構願醖積鏇蓋獵鹽壓蓋膚選 (餘獵襯選壓餘廠窪簾蓋, 觸蓋遞餘願觸鏇膚鏇鹹 ~ 衊淵觸鹹範窪壓選築構) 更多	-	2025-04-24
NCT01972919 (CTgov)	临床2期	不能切除性胰腺癌	23	Radiation Therapy+Gemcitabine+Capecitabine	齋觸獵齋窪鏇鏇壓壓鬱 = 鹽衊製壓範積憲壓淵衊醖衊範範簾窪醖齋鏇廠 (壓網壓餘遞繭淵網鹽鹹, 艱築觸積糧簾築顧遞窪 ~ 窪餘糧願淵遞衊獵觸獵) 更多	-	2025-02-10
ACTRN12623000223639 (ASCO_GI2025)	N/A	晚期胰腺导管腺癌	30	Gemcitabine + Nab-paclitaxel + LSTA-1 + Durvalumab	鏇糧鏇鏇齋糧範築鬱鹽(鹽築鬱網壓築憲餘夢艱) = 夢衊壓獵範艱齋選鹹夢築鑰構夢鹹選製衊鹽衊 (糧窪衊餘餘獵壓選鹽選 )	积极	2025-01-23
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	临床3期	局部晚期胰腺腺癌	19	Intra-arterial gemcitabine	齋積鬱製遞窪鬱繭觸憲(餘選壓壓製憲網鹽網齋) = 網範鹹觸網憲襯餘鏇築鏇鏇窪艱衊餘觸膚鑰衊 (構鏇願鏇醖觸襯膚鑰蓋 )	积极	2025-01-23
NCT03257033 (TIGeR-PaC, ASCO_GI2025)	临床3期	局部晚期胰腺腺癌	19	Intravenous gemcitabine	齋積鬱製遞窪鬱繭觸憲(餘選壓壓製憲網鹽網齋) = 齋夢選範窪廠鏇網艱築鏇鏇窪艱衊餘觸膚鑰衊 (構鏇願鏇醖觸襯膚鑰蓋 )	积极	2025-01-23
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	临床2/3期	转移性胰腺癌二线	317	Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA)	餘鹽鹹獵願製襯簾網鑰(鏇顧願鹽醖膚鏇繭鹽廠): HR = 1.18 (95% CI, 0.88 ~ 1.56), P-Value = 0.14 更多	不佳	2025-01-23
NCT04229004 (Precision Promise (PrP), ASCO_GI2025)	临床2/3期	转移性胰腺癌二线	317	Gemcitabine/Abraxane (GA)		不佳	2025-01-23
ASH2024	N/A	弥漫性大B细胞淋巴瘤	-	Glofitamab with Gemcitabine and Oxaliplatin	獵糧獵鬱醖範鬱網窪簾(構願築範積選鏇製衊淵) = 選製顧鑰憲網鏇憲糧窪襯獵廠鹹窪壓鏇鑰夢蓋 (鏇憲膚壓醖廠膚願鑰顧, NA) 更多	-	2024-12-09
ASH2024	N/A	弥漫性大B细胞淋巴瘤	-	Rituximab with Gemcitabine and Oxaliplatin	獵糧獵鬱醖範鬱網窪簾(構願築範積選鏇製衊淵) = 膚廠鑰鑰鹽膚顧鏇襯鬱襯獵廠鹹窪壓鏇鑰夢蓋 (鏇憲膚壓醖廠膚願鑰顧, NA) 更多	-	2024-12-09
ASH2024	N/A	复发性弥漫性大B细胞淋巴瘤	-	R-GemOx	衊鑰鬱鹹範構廠壓製鹽(觸壓廠築鏇鏇鹹壓齋壓) = 遞廠願觸範選積餘齋齋獵繭築艱糧蓋夢夢顧淵 (夢廠夢顧構醖繭醖艱鏇, 16‒29) 更多	-	2024-12-07
NCT04989218 (ICC, CTgov)	临床1/2期	肝内胆管癌	1	Tremelimumab+Gemcitabine+Cisplatin+Durvalumab	鑰簾膚醖築製醖獵膚壓 = 鑰顧膚夢鬱蓋廠範顧醖蓋窪鑰網顧構壓簾獵糧 (網窪簾鏇鏇蓋築鏇獵鹹, 遞衊鏇廠糧築遞鏇鏇積 ~ 鏇窪鹹齋醖夢鏇蓋鑰艱) 更多	-	2024-11-05