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

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 c

Trial Details

NCT ID

NCT07632235

Phase

PHASE1 / PHASE2

Sponsor

Shanghai 6th People's Hospital

Status

RECRUITING

Cancer Type

Adenocarcinoma Lung Cancer

Interventions

• Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin
• Pembrolizumab + Gemcitabine/Cisplatin

Locations (sample)

• Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

• Age ≥ 18 years.
• Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA).
• Unresectable locally advanced, recurrent, or metastatic disease.
• No prior systemic therapy for advanced disease.

For full eligibility, visit ClinicalTrials.gov.

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