PRODIGE 76-IMMUNOBILADJ: Capecitabine plus durvalumab or capecitabine alone as adjuvant therapy in patients with resected biliary tract carcinoma. A non-comparative randomized phase II study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503807-27-00

Enrollment

219

Registered

2023-07-07

Start date

Unknown

Completion date

2023-08-29

Last updated

2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract carcinoma

Brief summary

Disease-Free Survival rate at 18 months

Detailed description

Safety profile in two arms, DFS in two arms, overall survival in two arms, health-related Quality of life in the two arms, Prognostic and predictive biomarkers in terms of survival

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGCapecitabine Accord 150 mg film-coated tablets

DRUGCapecitabine Accord 300 mg film-coated tablets

DRUGCapecitabine Accord 500 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival rate at 18 months	—

Secondary

Measure	Time frame
Safety profile in two arms, DFS in two arms, overall survival in two arms, health-related Quality of life in the two arms, Prognostic and predictive biomarkers in terms of survival	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026