Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

August 16, 2023

Primary Completion Date

September 17, 2025

Study Completion Date

March 17, 2026

Conditions
Biliary Tract Cancer
Interventions
BIOLOGICAL

Durvalumab

Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as monotherapy)

DRUG

Gemcitabine monotherapy

Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

DRUG

Gemcitabine + cisplatin

Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only

DRUG

Gemcitabine + oxaliplatin

Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

DRUG

Gemcitabine + carboplatin

Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

DRUG

Gemcitabine + cisplatin + S-1

Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab)

DRUG

Gemcitabine + S-1

Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

DRUG

Gemcitabine + cisplatin + albumin-bound paclitaxel

Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

Trial Locations (34)

20007

Research Site, Washington D.C.

20089

Research Site, Rozzano

21079

Research Site, Dijon

28027

Research Site, Madrid

28040

Research Site, Madrid

28041

Research Site, Madrid

30625

Research Site, Hanover

31008

Research Site, Pamplona

31033

Research Site, Castelfranco Veneto

34090

Research Site, Montpellier

36607

Research Site, Mobile

41013

Research Site, Seville

56126

Research Site, Pisa

71122

Research Site, Foggia

90146

Research Site, Palermo

92110

Research Site, Clichy

92868

Research Site, Orange

94800

Research Site, Villejuif

97213

Research Site, Portland

169610

Research Site, Singapore

09131

Research Site, Chemnitz

104-0045

Research Site, Chūōku

920-8641

Research Site, Kanazawa

227-8577

Research Site, Kashiwa

606-8507

Research Site, Kyoto

541-8567

Research Site, Osaka

980-8574

Research Site, Sendai

755-8505

Research Site, Ube

641-8509

Research Site, Wakayama

241-8515

Research Site, Yokohama

03080

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

08035

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY