What type of study is this?

This is a Human Clinical Trial study (also classified as: Phase 2).

What question did this study set out to answer?

This trial aims to evaluate the efficacy and safety of re-introducing gemcitabine and cisplatin with durvalumab after progression during maintenance therapy in patients with biliary tract cancer.

January 14, 2026Journal of Clinical Oncology0 citations

Gemcitabine and Cisplatin with Durvalumab Re-Introduction for Biliary Tract Cancer

A phase II study of re-introduction of gemcitabine plus cisplatin in combination with durvalumab after durvalumab maintenance therapy in patients with unresectable or recurrent biliary tract cancer (PRIDE study).

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Authors

HTHiroyuki Takeda KUKumiko Umemoto RTRyoji Takada

Discussion

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Overview

Phase II trial evaluates safety and efficacy of GC re-introduction in patients with unresectable biliary tract cancer, suggesting improved outcomes post-maintenance therapy.

Key Points

This trial aims to evaluate the efficacy and safety of re-introducing gemcitabine and cisplatin with durvalumab after progression during maintenance therapy in patients with biliary tract cancer.
Prospective, multicenter, single-arm phase II study
Eligible patients: histologically/cytologically confirmed adenocarcinoma of intrahepatic or extrahepatic bile ducts
Treatment includes 3-week cycles of gemcitabine and cisplatin with durvalumab until disease progression or unacceptable toxicity
Primary endpoint: 6-month survival rate; secondary endpoints include overall survival and progression-free survival
Primary endpoint aims for a 6-month survival rate of 60% in a platinum-sensitive population
Secondary endpoints include evaluation of progression-free survival and safety
Expected benefit compared to historical data showing 50.6% survival with FOLFOX

Cite This Study

Takeda et al. (2026) studied this question.

synapsesocial.com/papers/6966f2f013bf7a6f02c003d2 https://doi.org/10.1200/jco.2026.44.2_suppl.tps609

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January 14, 2026Journal of Clinical Oncology0 citations

Gemcitabine and Cisplatin with Durvalumab Re-Introduction for Biliary Tract Cancer

View Full Paper

Ask AI

Bookmark

Authors

HTHiroyuki Takeda KUKumiko Umemoto RTRyoji Takada

Discussion

Member takes

Overview

Phase II trial evaluates safety and efficacy of GC re-introduction in patients with unresectable biliary tract cancer, suggesting improved outcomes post-maintenance therapy.

Key Points

This trial aims to evaluate the efficacy and safety of re-introducing gemcitabine and cisplatin with durvalumab after progression during maintenance therapy in patients with biliary tract cancer.
Prospective, multicenter, single-arm phase II study
Eligible patients: histologically/cytologically confirmed adenocarcinoma of intrahepatic or extrahepatic bile ducts
Treatment includes 3-week cycles of gemcitabine and cisplatin with durvalumab until disease progression or unacceptable toxicity
Primary endpoint: 6-month survival rate; secondary endpoints include overall survival and progression-free survival
Primary endpoint aims for a 6-month survival rate of 60% in a platinum-sensitive population
Secondary endpoints include evaluation of progression-free survival and safety
Expected benefit compared to historical data showing 50.6% survival with FOLFOX

Cite This Study

Takeda et al. (2026) studied this question.

synapsesocial.com/papers/6966f2f013bf7a6f02c003d2 https://doi.org/10.1200/jco.2026.44.2_suppl.tps609

View Full Paper

Ask AI

Bookmark