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ID DOID:4607
Name biliary tract cancer
Definition A hepatobiliary system cancer that results_in malignant growth located_in the gallbladder or located_in the bile duct.
Source DiseaseOntology.org
Alt Ids DOID:8092
Path disease disease of cellular proliferation cancer organ system cancer gastrointestinal system cancer hepatobiliary system cancer biliary tract cancer

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Molecular Profile Therapy Indication/Tumor Type Response Type Profile Response Detail
NRAS mutant Binimetinib biliary tract cancer predicted - sensitive detail...
FGFR2 fusion Futibatinib biliary tract cancer predicted - sensitive detail...
CDKN2A loss Palbociclib biliary tract cancer no benefit detail...
CDKN2A mutant Palbociclib biliary tract cancer no benefit detail...
BRAF V600E Dabrafenib + Trametinib biliary tract cancer sensitive detail...
PALB2 inact mut Rucaparib biliary tract cancer sensitive detail...
MSH6 negative Pembrolizumab biliary tract cancer sensitive detail...
MLH1 negative Pembrolizumab biliary tract cancer sensitive detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01828034 Phase Ib/II Binimetinib + Cisplatin + Gemcitabine First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma Completed USA 0
NCT01853618 Phase I Tremelimumab Tremelimumab With Chemoembolization or Ablation for Liver Cancer Completed USA 0
NCT02034110 Phase II Dabrafenib + Trametinib Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers Completed USA | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUT 5
NCT02053376 Phase II Regorafenib A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy Completed USA 0
NCT02091141 Phase II Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Completed USA 0
NCT02105350 Phase I Binimetinib + Gemcitabine + Oxaliplatin A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer Withdrawn 0
NCT02151084 Phase II Cisplatin + Gemcitabine + Selumetinib A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer Active, not recruiting CAN 0
NCT02240238 Phase Ib/II Gemcitabine + NC-6004 Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer Completed USA | ITA 3
NCT02265341 Phase II Ponatinib Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions Completed USA 0
NCT02268825 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Pembrolizumab Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers Terminated USA 0
NCT02451553 Phase I Afatinib Capecitabine Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer Completed USA 0
NCT02452970 Phase II RRx-001 Cisplatin + Gemcitabine RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy (EPIC) Terminated USA 0
NCT02454972 Phase II Lurbinectedin Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors Completed USA | ITA | GBR | FRA | ESP | DEU | BEL 2
NCT02576431 Phase II Larotrectinib A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors (NAVIGATE) Active, not recruiting USA | FRA | ESP | DEU 14
NCT02703714 Phase II Pembrolizumab + Sargramostim Pembrolizumab and GM-CSF in Biliary Cancer Completed USA 0
NCT02711553 Phase II Ramucirumab Merestinib Cisplatin + Gemcitabine A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer Active, not recruiting USA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 10
NCT02795156 Phase II Cabozantinib Afatinib Regorafenib Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Completed USA 0
NCT02821754 Phase Ib/II Durvalumab + Tremelimumab A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Completed USA 0
NCT02897375 Phase I Cisplatin + Palbociclib Carboplatin + Palbociclib Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Completed USA 0
NCT03093870 Phase II Capecitabine + Varlitinib Capecitabine Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer Completed USA | ESP | AUS 8
NCT03101566 Phase II Cisplatin + Gemcitabine + Nivolumab Ipilimumab + Nivolumab Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer Completed USA 0
NCT03111732 Phase II Capecitabine + Oxaliplatin + Pembrolizumab Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC) Completed USA 0
NCT03260712 Phase II Cisplatin + Gemcitabine + Pembrolizumab Pembrolizumab in Biliary Tract Cancer Completed GBR | ESP | DEU 0
NCT03337087 Phase Ib/II Fluorouracil + Leucovorin + Liposomal irinotecan + Rucaparib Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer Active, not recruiting USA 0
NCT03410927 Phase Ib/II TAS0728 A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities Terminated USA | GBR | FRA | ESP 0
NCT03482102 Phase II Durvalumab + Tremelimumab Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer Recruiting USA 0
NCT03639935 Phase II Nivolumab + Rucaparib Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Active, not recruiting USA 0
NCT03684811 Phase Ib/II Cisplatin + Gemcitabine + Olutasidenib Azacitidine + Olutasidenib Olutasidenib Nivolumab + Olutasidenib A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation Completed USA | GBR | FRA | ESP | AUS 1
NCT03704480 Phase II Durvalumab + Tremelimumab Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy (IMMUNO-BIL) Active, not recruiting FRA 0
NCT03768531 Phase II Cabiralizumab + Nivolumab Nivolumab Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer Withdrawn 0
NCT03785873 Phase Ib/II Fluorouracil + Irinotecan + Leucovorin + Nivolumab Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer Active, not recruiting USA 0
NCT03833661 Phase II Bintrafusp alfa M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) Completed USA | ITA | GBR | FRA | ESP 4
NCT03875235 Phase III Cisplatin + Gemcitabine Cisplatin + Durvalumab + Gemcitabine A Global Phase III Study of Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) Active, not recruiting USA | ITA | GBR | FRA 13
NCT03929666 Phase II Cisplatin + Gemcitabine Cisplatin + Fluorouracil + ZW25 Capecitabine + Oxaliplatin + ZW25 Fluorouracil + Leucovorin + Oxaliplatin + ZW25 Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin + ZW25 A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer Active, not recruiting USA | CAN 2
NCT03936959 Phase I LY3434172 A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer Completed USA | FRA | BEL | AUS 1
NCT03964233 Phase I BI 907828 + Ezabenlimab + Miptenalimab BI 907828 + Ezabenlimab A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) Active, not recruiting USA | NLD | GBR | FRA | ESP | DEU | BEL | AUS 3
NCT03991832 Phase II Durvalumab + Olaparib Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (SOLID) Recruiting CAN 0
NCT04003896 Phase II Abemaciclib A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy Terminated USA 0
NCT04066491 Phase II Cisplatin + Gemcitabine Bintrafusp alfa + Cisplatin + Gemcitabine Gemcitabine Plus Cisplatin With or Without M7824 in Participants With 1L Biliary Tract Cancer (BTC) Terminated USA | ITA | GBR | FRA | ESP | DEU | AUS 8
NCT04163900 Phase III Cisplatin + NUC-1031 Cisplatin + Gemcitabine Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer (NuTide:121) Terminated USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS 7
NCT04203160 Phase Ib/II Cisplatin + Gemcitabine Cisplatin + CPI-613 + Gemcitabine Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) Active, not recruiting USA 0
NCT04238637 Phase II Durvalumab Durvalumab + Tremelimumab Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC) Recruiting DEU 0
NCT04338685 Phase I RO7119929 + Tocilizumab A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases Completed USA | ESP 4
NCT04466891 Phase II ZW25 A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (HERIZON-BTC-01) Active, not recruiting USA | ITA | GBR | FRA | ESP | CAN 3
NCT04482309 Phase II Trastuzumab deruxtecan A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) Recruiting USA | NLD | ITA | GBR | ESP | CAN | BEL | AUS 9
NCT04491942 Phase I Cisplatin + Elimusertib Cisplatin + Elimusertib + Gemcitabine Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer Active, not recruiting USA | CAN 0
NCT04566133 Phase II Hydroxychloroquine + Trametinib Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). Terminated USA 0
NCT04578444 Expanded access ZW25 An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer Available USA | ITA | GBR | FRA | ESP 0
NCT04592653 Phase Ib/II ALKS 4230 ALKS 4230 + Pembrolizumab Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) (ARTISTRY-3) Recruiting USA | ESP 0
NCT04677504 Phase II Atezolizumab + Cisplatin + Gemcitabine Atezolizumab + Bevacizumab + Cisplatin + Gemcitabine A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer Completed USA | ITA | GBR | ESP 9
NCT04683939 Phase Ib/II BNT141 BNT141 + Gemcitabine + Nab-paclitaxel Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors Terminated USA | CAN 0
NCT04727541 Phase II Bintrafusp alfa Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer (NEOBIL) Terminated DEU 0
NCT04735796 Phase I LM-102 Study of LM-102 in Subjects in Advanced Tumors Terminated USA 0
NCT04779151 Phase II Dostarlimab-gxly + Niraparib Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NIRADO) Suspended FRA 0
NCT04907851 Phase II Denosumab + RXC004 Denosumab + Pembrolizumab + RXC004 A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (KEYNOTE-E86) Completed GBR | AUS 0
NCT04941287 Phase II Atezolizumab + Varlilumab Atezolizumab + Cobimetinib + Varlilumab Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of A Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer Active, not recruiting USA 0
NCT04969887 Phase II Ipilimumab + Nivolumab Combination Immunotherapy in Rare Cancers Under InvesTigation (MOST-CIRCUIT) Active, not recruiting NZL | AUS 0
NCT04976634 Phase II Belzutifan + Lenvatinib + Pembrolizumab Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) Recruiting USA | NZL | NLD | FRA | ESP | BEL | AUS 3
NCT05001516 Phase Ib/II TPX-4589 Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors Completed USA 0
NCT05041972 Phase II ARX-788 ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02) Withdrawn USA 0
NCT05052099 Phase Ib/II Atezolizumab + Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer (COMBATBIL) Recruiting ESP | DEU 0
NCT05074472 Phase Ib/II ZB131 A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors Completed USA 0
NCT05094336 Phase Ib/II AMG193 AMG193 + Docetaxel AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) Recruiting USA | GBR | FRA | DEU | CAN | BEL | AUT | AUS 5
NCT05239169 Phase II Capecitabine + Durvalumab + Tremelimumab Durvalumab + Tremelimumab Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer Active, not recruiting DEU 0
NCT05297903 Phase II XmAb20717 XmAb20717 in Advanced Biliary Tract Cancers Active, not recruiting USA 0
NCT05358379 Phase Ib/II CYC140 A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma Recruiting USA | ESP 1
NCT05451043 Phase II Cisplatin + Durvalumab + Gemcitabine + Propranolol + Tremelimumab Durvalumab + Gemcitabine + Nab-paclitaxel + Propranolol + Tremelimumab Durvalumab + Propranolol + Tremelimumab Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) Not yet recruiting CAN 0
NCT05482516 Phase III Atezolizumab + Bevacizumab Evaluating Novel Therapies in ctDNA Positive GI Cancers (MRD-GI) Recruiting USA 0
NCT05636215 Phase Ib/II Orismilast A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors Not yet recruiting AUS 0
NCT05733000 Phase II CPI-613 + Gemcitabine + Hydroxychloroquine CPI-613 + Hydroxychloroquine CPI-613 + Gemcitabine CPI-613 + Fluorouracil + Hydroxychloroquine CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Recruiting USA 0
NCT05771480 Phase III Durvalumab + Gemcitabine + Oxaliplatin Cisplatin + Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Durvalumab + Gemcitabine + Tegafur-gimeracil-oteracil Potassium Cisplatin + Durvalumab + Gemcitabine Durvalumab + Gemcitabine Carboplatin + Durvalumab + Gemcitabine Cisplatin + Durvalumab + Gemcitabine + Nab-paclitaxel Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (TOURMALINE) Recruiting USA | ITA | FRA | ESP | DEU 3
NCT05849480 Phase Ib/II Capecitabine + CDX-1140 + Oxaliplatin + Pembrolizumab A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) Recruiting USA 0
NCT05875168 Phase Ib/II DS-3939a First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors Recruiting USA 1
NCT06001658 Phase II Cisplatin + Gemcitabine + Pembrolizumab Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers Recruiting USA 0
NCT06024174 Phase Ib/II Adagrasib + BBP-398 + Cetuximab Adagrasib + BBP-398 A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors Active, not recruiting USA | ITA | FRA | ESP | BEL | AUS 2
NCT06048133 Phase II AB680 + Cisplatin + Gemcitabine + Zimberelimab Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers Recruiting USA 0
NCT06084481 Phase I ABBV-400 Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Recruiting USA 3
NCT06084689 Phase II BI 907828 + Ezabenlimab Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (EMPIRE) Not yet recruiting FRA 0
NCT06109779 Phase III AZD2936 + Cisplatin + Gemcitabine AZD2936 + Tegafur-gimeracil-oteracil Potassium AZD2936 + Capecitabine Capecitabine Tegafur-gimeracil-oteracil Potassium Cisplatin + Gemcitabine A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Bil01) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 12
NCT06242691 Phase II MK-1200 Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors Recruiting USA | AUS 1
NCT06282575 Phase III Cisplatin + Durvalumab + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab Cisplatin + Durvalumab + Gemcitabine + ZW25 Cisplatin + Gemcitabine Cisplatin + Gemcitabine + Pembrolizumab + ZW25 Cisplatin + Gemcitabine + ZW25 Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Recruiting USA 1
NCT06293898 Phase I BL-M07D1 Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors Recruiting USA 0
NCT06360354 Phase I AMG193 + Cisplatin + Gemcitabine + Pembrolizumab AMG193 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin AMG193 + Gemcitabine + Nab-paclitaxel A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion Recruiting USA 0