10 unknown, 5 recruiting, 4 active not recruiting, 3 completed. 21 Phase 2, 4 Phase 1, 3 Phase 3.
Follow Advanced Biliary Tract Cancer: new trials by email Literature Review of Advanced Biliary Tract Cancer trials Research Report on Advanced Biliary Tract Cancer
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers Zolbetuximab, mFOLFOX6, CAPOX - Advanced Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma | Phase 2 | Not yet recruiting | Midhun Malla | 32 | 2026-11-01 | 2026-11-02 |
| Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy gemcitabine, toripalimab, and lenvatinib capsules - Advanced Biliary Tract Cancer | Phase 2 | Not yet recruiting | Shanghai Zhongshan Hospital | 39 | 2026-10-12 | 2026-10-27 |
| A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer Nanvuranlat, Physician's Best Choice - Advanced Biliary Tract Cancer, Biliary Tract Cancer (BTC) | Phase 3 | Recruiting | J-Pharma Co., Ltd. | 480 | 2026-05-11 | 2026-09-29 |
| A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC) SHR-8068 Injection, Adebrelimab Injection, Gemcitabine Hydrochloride for Injection - Advanced Biliary Tract Cancer | Phase 3 | Recruiting | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 604 | 2026-01-21 | 2026-01-28 |
| A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer BL-B01D1, Pembrolizumab - Advanced Biliary Tract Cancer | Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 46 | 2025-06-10 | 2025-07-02 |
| GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1） GemCis plus PD-1/PD-L1 inhibitor - Advanced Biliary Tract Cancer | Recruiting | Fudan University | 100 | 2025-05-23 | 2025-05-29 | |
| Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer Surufatinib, Gemcitabine, Cisplatin - Advanced Biliary Tract Cancer | Phase 2 | Recruiting | Dai, Guanghai | 35 | 2024-08-15 | 2024-11-27 |
| Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer Cadonilimab+Regorafenib+GC - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Tianjin Medical University Cancer Institute and Hospital | 30 | 2023-09-01 | 2023-12-06 |
| Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS-05) H101, Tislelizumab, Lenvatinib - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Fudan University | 25 | 2023-05-16 | 2023-06-27 |
| Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer anlotinib+TQB2450+nab-paclitaxel+cisplatin - Advanced Biliary Tract Cancer | Phase 2 | Unknown | The First Affiliated Hospital of Zhengzhou University | 20 | 2023-04-10 | 2023-09-13 |
| Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer （CASTLE-08） Sintilimab, Lenvatinib, Cryoablation - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Fudan University | 25 | 2023-03-23 | 2023-03-24 |
| IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer IBI310, sintilimab - Advanced Biliary Tract Cancer | Phase 1 / Phase 2 | Unknown | Innovent Biologics (Suzhou) Co. Ltd. | 20 | 2023-03-10 | 2023-04-03 |
| Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN) Envofolimab, Lenvatinib, Gemcitabine - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Sun Yat-sen University | 43 | 2022-10-10 | 2022-10-12 |
| Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment Lenvatinib Pill,Paclitaxel - Advanced Biliary Tract Cancer | Phase 2 | Active not recruiting | National Health Research Institutes, Taiwan | 51 | 2022-07-01 | 2026-07-02 |
| The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers Durvalumab, Regorafenib - Advanced Biliary Tract Cancer | Phase 1 / Phase 2 | Active not recruiting | University of Kansas Medical Center | 40 | 2022-03-22 | 2026-01-23 |
| Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer Irinotecan Liposome Injection, SG001, Fluorouracil - Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma | Phase 2 | Terminated | CSPC Ouyi Pharmaceutical Co., Ltd. | 17 | 2021-09-01 | 2024-07-11 |
| Combination Immunotherapy in Rare Cancers Under InvesTigation Ipilimumab, Nivolumab - Advanced Biliary Tract Cancer, Neuroendocrine Tumors | Phase 2 | Active not recruiting | Olivia Newton-John Cancer Research Institute | 240 | 2021-08-03 | 2026-02-27 |
| A Phase 1/2 Study of SC-43 in Combination With Cisplatin SC-43, Cisplatin - Advanced Non-small-cell Lung Cancer, Advanced Biliary Tract Cancer | Phase 1 / Phase 2 | Unknown | RaND Biosciences | 100 | 2021-05-01 | 2021-02-02 |
| Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Sitravatinib, Tislelizumab - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Seoul National University Hospital | 43 | 2020-11-01 | 2024-04-19 |
| Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers Toripalimab plus Lenvatinib - Advanced Biliary Tract Cancer | Phase 2 | Unknown | Peking Union Medical College Hospital | 44 | 2020-08-11 | 2023-03-29 |
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Biliary Tract Neoplasms (3) · Cholangiocarcinoma (3) · Gallbladder Neoplasms (3) · Gastrointestinal Neoplasms (1) · Genital Neoplasms, Female (1) · Klatskin Tumor (1) · Neuroendocrine Tumors (1)
Neoplasms (6) · Neoplasms by Site (6) · Biliary Tract Diseases (5) · Digestive System Diseases (5) · Digestive System Neoplasms (5) · Neoplasms by Histologic Type (4) · Adenocarcinoma (3) · Carcinoma (3) · Gallbladder Diseases (3) · Neoplasms, Glandular and Epithelial (3) · Biliary Tract Neoplasms (2) · Female Urogenital Diseases (1) · Female Urogenital Diseases and Pregnancy Complications (1) · Gastrointestinal Diseases (1) · Genital Diseases (1)
Gemcitabine (5) · lenvatinib (5) · Cisplatin (4) · Fluorouracil (3) · Leucovorin (3) · durvalumab (3) · toripalimab (3) · Folfox protocol (2) · Nivolumab (2) · irinotecan sucrosofate (2) · pembrolizumab (2) · sintilimab (2) · tislelizumab (2) · Bevacizumab (1) · Cryosurgery (1)
Fudan University (3) · Dai, Guanghai (2) · National Health Research Institutes, Taiwan (2) · CSPC Ouyi Pharmaceutical Co., Ltd. (1) · Georgetown University (1) · Innovent Biologics (Suzhou) Co. Ltd. (1) · J-Pharma Co., Ltd. (1) · Midhun Malla (1) · Olivia Newton-John Cancer Research Institute (1) · Peking Union Medical College Hospital (1) · Peking University (1) · RaND Biosciences (1) · Seoul National University Hospital (1) · Shanghai Zhongshan Hospital (1) · Sichuan Baili Pharmaceutical Co., Ltd. (1)
China (14) · United States (5) · South Korea (2) · Taiwan (2) · Australia (1) · New Zealand (1)
Benjamin Weinberg, MD (1) · Chen Ming-Huang, MD (1) · Chiang Nai-Jung, MD (1) · Do-Youn Oh, M.D., PhD. (1) · Eric K Rowinsky, MD (1) · Ghassan Abou-Alfa, MD (1) · Haitao Zhao, MD (1) · In-Jae Oh, MD (1) · Jonathan Cebon, MD (1) · Li-Yuan Bai, MD,PhD (1) · Midhun Malla, MD, MS (1) · Ming Kuang, PhD (1) · Oliver Klein, MD (1) · Peng Wang (1) · Peng Wang, MD (1)
PMID 20375404, PMID 24769639, PMID 24852116, PMID 26179201, PMID 26598942, PMID 27095655, PMID 27234522, PMID 27806234, PMID 28818953, PMID 29341833, PMID 29433850, PMID 29882997, PMID 30515783, PMID 30642373, PMID 30646854, PMID 30755690, PMID 30811474, PMID 31081949, PMID 31403867, PMID 31407173, PMID 31501784, PMID 33198671, PMID 40608313, PMID 40885799, PMID 41231502, PMID 41297674, PMID 41983220