Biliary Tract Neoplasms clinical trials
The registry lists 519 studies for Biliary Tract Neoplasms across more than 10 countries. 199 are recruiting or about to start. 314 of them are mainly about Biliary Tract Neoplasms (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-10. Counting its 2 narrower conditions too, such as Gallbladder Neoplasms: 891 studies, 276 open.
ClinicalTrials.gov finds 1,109 studies for Biliary Tract Neoplasms. How that becomes 519 here
This page counts the studies the registry files under Biliary Tract Neoplasms, and those it files under no condition that list Biliary Tract Neoplasmsthemselves. Each study its search finds is placed by how the registry filed it and by the conditions it lists. ClinicalTrials.gov counts as of Nov 8, 2026. How condition pages count
- 1,109Found by its condition searchIt reads the conditions a study lists and their synonyms, and also titles and keywords.
- −364Filed under a narrower condition, counted on its own pageGallbladder Neoplasms 233 · Bile Duct Neoplasms 131
- −3List Biliary Tract Neoplasms as a condition, but the registry did not file them under itMost often written as “Advanced Biliary Tract Cancer” (1), “Advanced Biliary Tract Cancer(BTC)” (1), and “Liver and Intrahepatic Biliary Tract Cancer” (1). The registry filed them under other conditions only, most often Neuroendocrine Tumors (1) and Genital Neoplasms, Female (1).
- −223Match it another way35 name it in the title, 4 in a keyword, and 184 by a synonym or other text the search reads.
- 519The count on this page35 of them list Biliary Tract Neoplasms in their own words; the registry filed them under no condition.
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Status
Who runs them
AstraZeneca (18) · Peking Union Medical College Hospital (16) · Kansai Hepatobiliary Oncology Group (10) · Fudan University (10) · Shanghai Zhongshan Hospital (10) · National Health Research Institutes, Taiwan (8) · National Cancer Institute (NCI) (8) · Samsung Medical Center (8)
What is being tested here
Drugs under test in Biliary Tract Neoplasms studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Gemcitabine | 8 | 4 | 45 |
| Lenvatinib | 7 | 0 | 15 |
| Adebrelimab | 7 | 0 | 8 |
| Cisplatin | 6 | 4 | 25 |
| Durvalumab | 4 | 3 | 15 |
| Fluorouracil | 4 | 2 | 14 |
| Zanidatamab | 4 | 3 | 6 |
| Ivonescimab | 4 | 1 | 5 |
| Sacituzumab tirumotecan | 4 | 0 | 4 |
| Capecitabine | 3 | 1 | 15 |
Drug classes tested here Immune checkpoint inhibitors 40 open · Tyrosine kinase inhibitors (TKIs) 19 open · Antimetabolites 16 open · Antibody-drug conjugates (ADCs) 10 open · Antimitotic agents 2 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
The 10 nearest, phase 3 first
- Jun 2027Personalized Medicine for Advanced Biliary Cancer Patients · Phase 3 · UNICANCER
- Aug 2027A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) · Phase 3 · Compass Therapeutics
- Oct 2027A 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 · Phase 3 · J-Pharma Co., Ltd.
- Nov 2026AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 · AstraZeneca
- Nov 2026A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) · Amgen
- Nov 2026Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CT · Beijing Tsinghua Chang Gung Hospital
- Dec 2026Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Dec 2026Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer · Tongji Hospital
- Dec 2026A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. · Fujian Cancer Hospital
- Dec 2026This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors · Zumutor Biologics Inc.
Who these studies take
Of the 140 Biliary Tract Neoplasms studies recruiting now, 80 (57%) set no upper age limit and 37 (26%) stop at 75 or younger. 6 (4%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 4 (3%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 4 (3%) | 4 (3%) |
| 18 | 130 (93%) | 130 (93%) |
| 30 | 139 (99%) | 139 (99%) |
| 40 | 140 (100%) | 140 (100%) |
| 50 | 140 (100%) | 140 (100%) |
| 65 | 140 (100%) | 140 (100%) |
| 75 | 135 (96%) | 135 (96%) |
| 85 | 91 (65%) | 91 (65%) |
Across all 519 studies, recruiting or not: 18% stop at 75 or younger and <1% at 65; 3% take children; 0% are for women only and 0% for men only; 2% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Biliary Tract Neoplasms studies take
Of 129 phase 2 interventional studies under Biliary Tract Neoplasms, half reached primary completion within 39 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 1 | 37 mo30–… · 34 studies | — | — |
| Phase 1/2 | 60 mo33–68 · 48 studies | — | — |
| Phase 2 | 39 mo29–68 · 129 studies | — | 39 mo29–60 · 99 studies |
| Interventional, no phase | 35 mo26–63 · 25 studies | — | — |
| Observational | 58 mo37–132 · 44 studies | — | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 13, 2026.
Started recruiting2
Results posted3
- A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal CancerNov 4, 2026NCT03929666
- NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary CancerOct 27, 2026NCT04005339
- Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or BladderOct 14, 2026NCT05512377
Stopped2
- Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract CancerTerminatedNov 4, 2026NCT05065957
- Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract CancerSuspendedOct 20, 2026NCT07146646
Newly registered7
- Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract CancerNov 4, 2026NCT07916844
- Daraxonrasib in Asian RAS-mutant Biliary Tract CancerNov 2, 2026NCT07908550
- CR-002 in Adult Participants With Locally Advanced or Metastatic Solid TumorsNov 2, 2026NCT07909031
- Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CTNov 2, 2026NCT07911397
- Clinical Spectrum and Long-term Outcomes of Congenital Biliary DilatationOct 29, 2026NCT07903077
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Studies
Recruiting first, then most recently updated. Showing 50 of 519. Browse all 519 → or search them.
- A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid TumorsRecruitingNCT07020221Phase 1/24 countries
- Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing PancreatectomyNot yet recruitingNCT07608458Not applicable1 country
- Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract CancerNot yet recruitingNCT07793253Phase 21 country
- Tissue Procurement and Natural History Study of Patients With Malignant MesotheliomaRecruitingNCT019505721 country
- D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract CancerRecruitingNCT06622057Phase 32 countries
- A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)RecruitingNCT06760819Phase 211 countries
- Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract CancerNot yet recruitingNCT07916844Phase 31 country
- Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CTNot yet recruitingNCT07911397Not applicable1 country
- Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract CancersNot yet recruitingNCT07723534Phase 21 country
- CR-002 in Adult Participants With Locally Advanced or Metastatic Solid TumorsRecruitingNCT07909031Phase 1/21 country
- Daraxonrasib in Asian RAS-mutant Biliary Tract CancerNot yet recruitingNCT07908550Phase 21 country
- A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)RecruitingNCT05849480Phase 1/21 country
- A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)RecruitingNCT06428409Phase 1/213 countries
- Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract CancerRecruitingNCT06282575Phase 325 countries
- Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional ChemotherapyNot yet recruitingNCT07897565Phase 2
- A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid MalignanciesRecruitingNCT07197554Phase 11 country
- Vedotin for Injection in Second-line or Later Treatment of Advanced Biliary Tract CancerEnrolling by invitationNCT07890311Phase 21 country
- A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)RecruitingNCT06330064Phase 1/218 countries
- Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node MetastasesRecruitingNCT07893392Phase 21 country
- A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid TumorsRecruitingNCT07807956Phase 11 country
- AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)RecruitingNCT07038343Phase 1/22 countries
- A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) MutationRecruitingNCT07458347Phase 11 country
- Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract CancerRecruitingNCT07159204Phase 21 country
- Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar CholangiocarcinomaRecruitingNCT07030140Phase 21 country
- Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid TumorsRecruitingNCT06239194Phase 1/21 country
- Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400RecruitingNCT06084481Phase 18 countries
- Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid TumorsRecruitingNCT06293898Phase 11 country
- Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract CancerRecruitingNCT06467357Phase 327 countries
- Bile ctDNA Genomic Profiling and Concordance With Tumor Tissue in Biliary Tract CancerNot yet recruitingNCT078306281 country
- A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract CancerRecruitingNCT07850791Phase 21 country
- A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract CancerRecruitingNCT07854600Phase 21 country
- Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract TumorsNot yet recruitingNCT07841873Phase 2
- AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2RecruitingNCT06219941Phase 214 countries
- 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 CancerRecruitingNCT07265674Phase 31 country
- A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)RecruitingNCT07221253Phase 319 countries
- Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)RecruitingNCT05482893Phase 1/21 country
- Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid TumorRecruitingNCT05523947Phase 1/23 countries
- Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)RecruitingNCT05489211Phase 214 countries
- Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer.Not yet recruitingNCT07829874Phase 21 country
- Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract CancerRecruitingNCT07831993Phase 21 country
- A Single-arm, Multicenter Clinical Study of Iparomlimab and Toripalimab in Combination With Bevacizumab and Chemotherapy as First-line Treatment for Advanced Biliary Tract CancerRecruitingNCT07619235Phase 41 country
- Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary ObstructionNot yet recruitingNCT07811791Not applicable1 country
- Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)RecruitingNCT071618691 country
- SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid TumorsRecruitingNCT07812805Phase 12 countries
- CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for RecurrenceRecruitingNCT06037980Phase 2/31 country
- CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract CancersRecruitingNCT06548412Phase 1/21 country
- Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract CancerRecruitingNCT07797816Phase 21 country
- Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer PatientsRecruitingNCT06529718Phase 22 countries
- Tucatinib Continuation StudyNot yet recruitingNCT07768358Phase 4
- A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid TumorsRecruitingNCT05150691Phase 1/26 countries