Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs) - TOURMALINE

Study identifier:D4191C00140

ClinicalTrials.gov identifier:NCT05771480

EudraCT identifier:2022-002527-35

CTIS identifier:2022-502043-35

Recruiting

Official Title

A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers (TOURMALINE)

Medical condition

biliary tract cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Gemcitabine monotherapy, Gemcitabine + cisplatin, Gemcitabine + oxaliplatin, Gemcitabine + carboplatin, Gemcitabine + cisplatin + S-1, Gemcitabine + S-1, Gemcitabine + cisplatin + albumin-bound paclitaxel

Sex

All

Estimated Enrollment

140

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Aug 2023
Estimated Primary Completion Date: 17 Sept 2025
Estimated Study Completion Date: 17 Mar 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria