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Biliary Tract Neoplasms clinical trials

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NCT ID: NCT06037980 Recruiting - Cholangiocarcinoma Clinical Trials

CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence

PURITY
Start date: November 7, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence.

NCT ID: NCT06037655 Not yet recruiting - Clinical trials for Biliary Tract Neoplasms

Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

Modified
Start date: September 25, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

NCT ID: NCT06017297 Recruiting - Clinical trials for Biliary Tract Cancer

Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

ESR-22-21719
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge patients to a curative resection in treatment naïve borderline resectable, or resectable with high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it aims to answer are: - What is the rate of conversion of unresectable tumor to resectable cancer? - What are the side effects of this treatment combination? Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection. If the tumor is unresectable (can't be surgically removed) after 4 cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months.

NCT ID: NCT06001658 Recruiting - Pancreatic Cancer Clinical Trials

Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

Start date: May 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.

NCT ID: NCT05998447 Recruiting - Clinical trials for Biliary Tract Cancer

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

Start date: September 18, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase

NCT ID: NCT05994001 Recruiting - Clinical trials for Biliary Tract Cancer

Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody

Start date: August 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1 monoclonal antibody and CTLA-4 monoclonal antibody bisspecific antibodies) and LM-302 (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC and PD1/PD-L1 monoclonal antibody treatment.

NCT ID: NCT05985707 Not yet recruiting - Clinical trials for HER2-positive Colorectal Cancer

KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma

Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 (a PD-L1/CTLA-4 targeted bispecific antibody).

NCT ID: NCT05942807 Recruiting - Clinical trials for Biliary Tract Cancer

Observational Monocentric Study on Biliary Tract Cancer (BABEL)

BABEL
Start date: May 15, 2021
Phase:
Study type: Observational

BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

NCT ID: NCT05935579 Recruiting - Immunotherapy Clinical Trials

Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

Start date: December 14, 2022
Phase: Phase 2
Study type: Interventional

Explore the impact of the first-line application of Durvalumab combined with Lenvatinib, with or without chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers.

NCT ID: NCT05924880 Active, not recruiting - Clinical trials for Biliary Tract Cancers

A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)

TopDouble
Start date: July 21, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with aBTC with a WHO/ECOG PS of 0 to 2 at enrolment.