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)

Sponsor
AstraZeneca
Study ID
NCT05924880
Phase
PHASE3
Status
Completed

Conditions

  • Biliary Tract Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • durvalumab — DRUG
    Durvalumab 1500 mg as a 60-minute IV infusion in combination with gemcitabine-based chemotherapy Q3W. Upon completing chemotherapy, or discontinuing chemotherapy due to toxicity, durvalumab 1500 mg IV Q4W alone or in combination with gemcitabine.

Study Details

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.

Key Dates

Start date
Jul 21, 2023
Status verified
Mar 2025
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025

Study Design

Enrollment
116 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab in combination with gemcitabine-based chemotherapy
    single-arm

Primary Outcome Measure

The incidence of Possible related adverse events(PRAE) Grade 3 or 4 [ Time Frame: Within 6 months after the initiation of study intervention. ]

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