Study of Adding Celecoxib to Pembrolizumab and GemcitabineCisplatin Treatment in Adults With Advanced CK56-High Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating whether adding celecoxib to the standard treatment of pembrolizumab combined with gemcitabine and cisplatin can improve outcomes in patients with advanced intrahepatic cholangiocarcinoma who have high CK56 biomarker levels. This study is a randomized, open-label phase IbII trial aiming to identify more precise treatment strategies based on patient subgroups and biomarker status. Participants will be randomly assigned to either the control group receiving pembrolizumab with gemcitabine and cisplatin, or the experimental group receiving the same standard treatment plus oral celecoxib taken twice daily. Each treatment cycle lasts 21 days, with cisplatin administered for up to 8 cycles. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. Celecoxib starts one week before the first cycle and is taken continuously. During the study, participants will undergo regular imaging scans, lab tests, and safety evaluations to monitor tumor response and side effects. Blood and tissue samples will be collected to study tumor biology and biomarkers. The main outcomes measured include progression-free survival and objective response rate, along with safety. Researchers will manage any treatment-related adverse events, and monitoring continues until treatment ends or the disease progresses.

A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma