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Study identifier: NCT07632235 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Intrahepatic Cholangiocarcinoma (Icc)  ·  Sponsor: Shanghai 6th People's Hospital

PhasePhase 1/Phase 2
Planned participants112
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study aims to evaluate whether adding celecoxib to standard therapy can improve clinical outcomes in patients with advanced intrahepatic cholangiocarcinoma. The current standard treatment typically consists of immunotherapy combined with chemotherapy; however, there are significant inter-patient differences in treatment response. Therefore, this study further introduces the biomarker CK5/6 to identify patient subgroups who are more likely to benefit, thereby exploring a more precise therapeutic strategy. All eligible participants will be randomly assigned after enrollment to either the control group or the experimental group. The control group will receive the current standard first-line regimen, which includes the immunotherapy agent pembrolizumab combined with the chemotherapy agents gemcitabine and cisplatin. The experimental group will receive the same standard treatment, with the addition of oral anti-inflammatory therapy with celecoxib taken twice daily throughout the entire treatment period. Each treatment cycle lasts 21 days. During treatment, patients will undergo regular imaging assessments, laboratory tests, and safety evaluations to monitor tumor response and treatment-related adverse events, and will be followed until disease progression or discontinuation of treatment. In addition, blood and tissue samples will be collected during the study to investigate tumor biology and potential predictive biomarkers. The primary endpoints of this study include progr…

This description comes directly from the study's public registry record.

Talk to the study team

Chen Yang  ·  86 18160747569  ·  18160747569@163.com

Haiyan Hu  ·  xuri1104@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Renji HospitalShanghai, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07632235