Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

November 6, 2028

Study Completion Date

November 6, 2028

Conditions
Extrahepatic CholangiocarcinomaPerihilar CholangiocarcinomaDistal CholangiocarcinomaResectableBorderline Resectable
Interventions
DRUG

Pembrolizumab

Patients will initiate with 2 sets of 3 cycles of neoadjuvant gemcitabine and cisplatin in combination with perioperative pembrolizumab (up to total of 1 year immunotherapy treatment)

DRUG

Gemcitabine, Cisplatin

Patients will initiate with 2 sets of 3 cycles of neoadjuvant gemcitabine and cisplatin in combination with perioperative pembrolizumab (up to total of 1 year immunotherapy treatment)

Trial Locations (1)

Unknown

Amsterdam University Medical Center, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Maastricht University Medical Center

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

University Medical Center Groningen

OTHER

collaborator

Erasmus Medical Center

OTHER

lead

Amsterdam UMC, location VUmc

OTHER

NCT06923475 - Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma | Biotech Hunter | Biotech Hunter