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Biliary Tract Neoplasms clinical trials

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NCT ID: NCT04401709 Recruiting - Clinical trials for Biliary Tract Cancer

Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval. Drug Dose and Schedule: - Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 - Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14

NCT ID: NCT04352023 Active, not recruiting - Pancreatic Cancer Clinical Trials

Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural

Start date: January 1, 2018
Phase: Phase 2
Study type: Interventional

Prospective, single institute based, open label, double arm, randomized controlled trial Hypothesis: Pain control after resection of hepatobiliary tumors in patients with PCEA is more effective than in patients with IV-PCA.

NCT ID: NCT04338685 Completed - Clinical trials for Carcinoma, Hepatocellular

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

Start date: July 16, 2020
Phase: Phase 1
Study type: Interventional

Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.

NCT ID: NCT04333927 Active, not recruiting - Clinical trials for Biliary Tract Cancer

Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

ACCORD
Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

NCT ID: NCT04329429 Active, not recruiting - Clinical trials for Biliary Tract Cancer

A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.

NCT ID: NCT04318834 Recruiting - Clinical trials for Biliary Tract Cancer

Molecular Profiling of Advanced Biliary Tract Cancers

COMPASS-B-MUHC
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Biliary tract cancer (BTC) accounts for <1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.

NCT ID: NCT04308174 Active, not recruiting - Cholangiocarcinoma Clinical Trials

Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

DEBATE
Start date: May 20, 2020
Phase: Phase 2
Study type: Interventional

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.

NCT ID: NCT04300959 Recruiting - Clinical trials for Biliary Tract Cancer

Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer

NCT ID: NCT04298021 Active, not recruiting - Chemotherapy Effect Clinical Trials

DDR-Umbrella Study of DDR Targeting Agents in Advanced Biliary Tract Cancer

Start date: June 25, 2020
Phase: Phase 2
Study type: Interventional

To assess the effect of AZD6738 and Durvalumab combination or AZD6738 and Olaparib combination in biliary tract cancer patients who have failed to 1st-line chemotherapy.

NCT ID: NCT04298008 Recruiting - Chemotherapy Effect Clinical Trials

AZD6738 Plus Durvalumab in Biliary Tract Cancer

Start date: June 25, 2020
Phase: Phase 2
Study type: Interventional

This trial will enroll advanced biliary tract cancer patients who have been previously treated with immunotherapy in either the 2nd or 3rd line. Patients will be treated with AZD6738 and Durvalumab combination.