A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizu… (NCT07632235) | Clinical Trial Compass
RecruitingPhase 1/2
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
China112 participantsStarted 2026-07-01
Plain-language summary
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 progression-free survival and objective response rate, along with concurrent safety evaluation. Adverse events potentially associated with chemotherapy, immunotherapy, and celecoxib may occur, such as bone marrow suppression, gastrointestinal reactions, immune-related inflammatory responses, as well as renal or cardiovascular toxicities. The study team will closely monitor and promptly manage all adverse events.
This study aims to explore a CK5/6-based stratified personalized combination therapy strategy, with the goal of improving treatment benefit in patients with advanced intrahepatic cholangiocarcinoma and providing evidence for optimizing future clinical treatment strategies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
* At least one measurable lesion according to RECIST v1.1.
* ECOG performance status of 0-1.
* Availability of adequate pre-treatment tumor tissue for central pathological review.
* CK5/6 H-score ≥ 1.0 as determined by central laboratory testing.
* Adequate organ and bone marrow function as defined by protocol-specified laboratory criteria.
* Patients with biliary obstruction must have undergone effective drainage and achieved clinical stabilization prior to enrollment.
* Ability to provide written informed consent.
Exclusion Criteria:
* Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma.
* CK5/6 H-score \< 1.0.
* Prior systemic therapy for advanced or metastatic disease.
* Active gastrointestinal bleeding, peptic ulcer disease, or high risk of gastrointestinal perforation.
* Recent history of significant cardiovascular events including myocardial infarction, stroke, uncontrolled hypertension, or severe heart failure.
* Known hypersensitivity to celecoxib, sulfonamides, NSAIDs, or aspirin-exacerbated respiratory disease.
* Active autoimmune disease or conditions contraindicating pembrolizumab therapy.
* Severe renal impairment.
* Child-Pugh class C hepatic impairment.
* Acti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for patients whose tumors test 'CK5/6-high' — can you test my tumor to see if it meets that marker, and what does it mean for my treatment options if it does or doesn't?
2Since this is a Phase Ib/II trial that hasn't started recruiting yet, what does that early stage mean for what's already known about the safety of adding celecoxib to pembrolizumab and gemcitabine/cisplatin — and how does that uncertainty compare to just doing the standard combination without celecoxib?
3The trial is measuring progression-free survival as its main goal — can you explain what that means in practical terms for someone with my diagnosis, and how it compares to what we'd expect from the standard pembrolizumab plus gemcitabine and cisplatin regimen outside of a trial?
4Given that this study isn't recruiting yet, how long might it realistically be before I could even enroll, and is it safer for me to start standard treatment now rather than waiting?
5Celecoxib is an anti-inflammatory drug being added to the immunotherapy and chemotherapy — can you walk me through any additional side effects or risks I should be aware of from that combination, especially given my overall health right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.