Clinical trials: Metastatic Biliary Tract Cancer
Biliary Tract Cancer, Colorectal Carcinoma
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal…
- Conditions
- Biliary Tract Cancer, Colorectal Carcinoma, Gastric Cancer, Metastatic, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
- Trial name
- NCT06937567
- Testing
- CDH17 CAR-T, FAST LACO-Stim CDH17 CAR-T
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Zhejiang University
Patient Reported Outcome Measures, Colorectal Cancer
Predicting Disease Progression and/or Recurrence in Cancer
This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer…
- Conditions
- Patient Reported Outcome Measures, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer
- Trial name
- NCT04776837
- Testing
- Observational Cohort
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Massachusetts General Hospital
Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer
Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer
Biliary tract carcinoma (BTC) is a highly aggressive malignancy with rising incidence worldwide. Most patients present at an advanced stage and have a dismal prognosis.
- Trial name
- NCT07530445
- Testing
- Drug: QL1706 5mg/kg, iv drip,d1,Q3W; Albumin-Bound Paclitaxel 125mg/m2, iv drip, d1、d8, Q3W; Lenvatinib 8mg, po, QD
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Metastatic Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma
Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor…
- Trial name
- NCT07107750
- Testing
- Emavusertib, Gemcitabine, Cisplatin
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Washington University School of Medicine
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
This 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
This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are…
- Conditions
- Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma, Biliary Tract Cancer
- Trial name
- NCT06451497
- Testing
- ZM008
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Zumutor Biologics Inc.
Biliary Tract Cancer (BTC), Biliary Tract Cancer (CCA)
TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort
Purpose of the Study: Bile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed.
- Conditions
- Biliary Tract Cancer (BTC), Biliary Tract Cancer (CCA), Gall Bladder Cancer, Biliary Tract Cancers (BTC)
- Trial name
- TRACE-BTC (NCT07454486)
- Where
- Denmark
- Volunteers
- 300 people
- Sponsor
- Aarhus University Hospital
Solid Tumor, Advanced Cancer
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer
- Trial name
- NCT04900818
- Testing
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy, TJ033721 (givastomig), chemotherapy
- Where
- 21 sites in United States, China
- Volunteers
- 330 people
- Sponsor
- I-Mab Biopharma US Limited
Cancer Pain, Visceral Pain
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL).
- Conditions
- Cancer Pain, Visceral Pain, Gastrointestinal Neoplasms, Cancer of Gastrointestinal Tract
- Trial name
- NCT04907643
- Testing
- PICO G2 4k
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- Cedars-Sinai Medical Center
Adenocarcinoma Metastatic, Biliary Tract Cancer
Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer
AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial
- Conditions
- Adenocarcinoma Metastatic, Biliary Tract Cancer, Adenocarcinoma of the Biliary Tract, Adenocarinoma Locally Advanced
- Trial name
- NIFE (NCT03044587)
- Testing
- Arm NaI-IRI + 5-FU + Leucovorin (Arm A), Arm Cisplatin + Gemcitabine (Arm B)
- Where
- Germany
- Volunteers
- 93 people
- Sponsor
- AIO-Studien-gGmbH
Locally Advanced Biliary Tract Cancers, Metastatic Biliary Tract Cancers
Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer
This is a multicenter Phase 1b/2 clinical trial investigating the efficacy and safety of a combination regimen of Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab in treatment-naïve patients with unresectable, locally…
- Trial name
- GENTIS (NCT06893380)
- Testing
- Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab.
- Where
- South Korea
- Volunteers
- 61 people
- Sponsor
- CHA University
Biliary Tract Cancer, HER2-positive Cancer
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or…
- Conditions
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma
- Trial name
- TAB-2 (NCT07062263)
- Testing
- Trastuzumab, Chemotherapy
- Where
- 6 sites in India
- Volunteers
- 220 people
- Sponsor
- Tata Memorial Centre
HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
- Trial name
- NCT06778031
- Testing
- SHR-A1811, SHR-1316, SHR-8068
- Where
- 2 sites in China
- Volunteers
- 54 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Metastatic Biliary Tract Cancer, HER2 Positive
Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance…
- Trial name
- NCT06818773
- Testing
- Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor
- Volunteers
- 35 people
- Sponsor
- Eastern Hepatobiliary Surgery Hospital
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer
First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)
Biliary tract cancer is a rare malignant neoplasm including intrahepatic cholangiocarcinoma (IhCCA), extrahepatic cholangiocarcinoma (EhCCA) and Gallbladder cancer (GBC).
- Trial name
- NCT05749900
- Testing
- Trastuzumab+Nivolumab+Gemcitabine+Cisplatin
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Solid Tumor, Gastric Cancer
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
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Metastatic Biliary Tract Carcinoma, Metastatic Colorectal Carcinoma
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
This phase I/II trial studies the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium and to see how well they work in treating patients with pancreatic…
- Conditions
- Metastatic Biliary Tract Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Digestive System Neoplasm
- Trial name
- NCT03337087
- Testing
- Fluorouracil, Irinotecan Sucrosofate, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Academic and Community Cancer Research United
Metastatic Biliary Tract Cancer
Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer
The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are: To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line…
- Trial name
- NCT06282120
- Testing
- Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Metastatic Breast Carcinoma, Locally Advanced Breast Cancer
Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients
Study objective: Cohort 1: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification.
- Conditions
- Metastatic Breast Carcinoma, Locally Advanced Breast Cancer, Cancer of Pancreas, Solid Tumor With Intermediate or High HER2 Expression
- Trial name
- VUBAR (NCT03924466)
- Testing
- 68GaNOTA-Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 55 people
- Sponsor
- Universitair Ziekenhuis Brussel
Solid Tumor, Adult, Pancreatic Ductal; Adenocarcinoma
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors
This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where…
- Conditions
- Solid Tumor, Adult, Pancreatic Ductal; Adenocarcinoma, Ovarian Serous Adenocarcinoma, Biliary Cancer Metastatic
- Trial name
- NCT05074472
- Testing
- ZB131
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- ZielBio, Inc.
Biliary Tract Cancer, Metastatic Cancer
Pembrolizumab in Biliary Tract Cancer
This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in…
- Conditions
- Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer, Gallbladder Cancer
- Trial name
- NCT03260712
- Testing
- Pembrolizumab, Cisplatin, Gemcitabine
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC