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Compares treatment options for Intrahepatic Cholangiocarcinoma (Icc)
Official title 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
ClinicalTrials.gov ID: NCT07632235
What this study is testing
What is Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin?
Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for intrahepatic cholangiocarcinoma (icc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full 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.
- 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.
- 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.
- Active uncontrolled infection.
- Any condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.