Intrahepatic Cholangiocarcinoma (Icc)Phase 1/2NCT07632235
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
A Phase 1/2 study testing Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin and Pembrolizumab + Gemcitabine/Cisplatin in people with Intrahepatic Cholangiocarcinoma (Icc), run by Shanghai 6th People's Hospital at 5 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin and Pembrolizumab + Gemcitabine/Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 5 sitesChina
- Study dates
- 15 Sep 2026to 31 Dec 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Haiyan Hu contact
5 sites in 1 country
China5 sites
Sun Yat-sen University Cancer Center
Guangzhou
Rongce Zhao, 13610360027, zhaorc@sysucc.org.cn
Renji Hospital
Shanghai
Cun Wang, 86 18160747569, 18160747569@163.com
Shanghai 10th People's Hospital
Shanghai
Jun Li, 18930560396, lijundfgd1@163.com
Shanghai Sixth People's Hospital
Shanghai
Haiyan Hu, 18258766382, xuri1104@163.com
Wuhan TongJi Hospital
Wuhan
Chao Leng, 13554632993, lengchaojdld@163.com
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 therapy with celecoxib taken twice daily throughout the entire treatment period.
Read more
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 endpoint of this study is progression-free survival. Potential treatment-related adverse events associated with chemotherapy, immunotherapy, and celecoxib may include bone marrow suppression, gastrointestinal reactions, immune-related inflammatory responses, and renal or cardiovascular toxicities. The study team will closely monitor participants for adverse events and provide timely and appropriate management as necessary.
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.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin, Pembrolizumab + Gemcitabine/Cisplatin
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib + Pembrolizumab + Gemcitabine/CisplatinDrug
Celecoxib is administered orally at 200 mg twice daily (BID), starting 7 days before Cycle 1 Day 1 (C1D-7) in the experimental arm. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin is administered for a maximum of 8 cycles. Study treatment is continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria.
Pembrolizumab + Gemcitabine/CisplatinDrug
Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin is administered for a maximum of 8 cycles. Study treatment is continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin | Experimental | Participants receive celecoxib in combination with pembrolizumab and gemcitabine plus cisplatin chemotherapy. Celecoxib is administered orally at 200 mg twice daily (BID), starting 7 days before Cycle 1 Day 1 (C1D-7) and continued thereafter. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin is administered for a maximum of 8 cycles. Study treatment is continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria. Receives: Drug: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin |
| Active Comparator: Pembrolizumab + Gemcitabine/Cisplatin | Active comparator | Participants receive pembrolizumab in combination with gemcitabine plus cisplatin chemotherapy. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) are administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin is administered for a maximum of 8 cycles. Study treatment is continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria. Receives: Drug: Pembrolizumab + Gemcitabine/Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from randomization to first documented disease progression per RECIST v1.1 criteria or death from any cause. Disease progression will be assessed by imaging according to RECIST v1.1.
Measured: Up to 24 months
Secondary outcomes (5)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria in both treatment arms.
Measured: Up to 24 months
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants achieving complete response, partial response, or stable disease according to RECIST v1.1 criteria.
Measured: Up to 24 months
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 36 months
Duration of Response (DoR)
Duration of response is defined as the time from first documented objective response (CR or PR) to disease progression or death.
Measured: Up to 24 months
Safety and Tolerability
Safety and tolerability will be assessed by incidence, severity, and type of adverse events graded according to CTCAE v5.0.
Measured: From first dose until 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Wuhan TongJi Hospital, Sun Yat-Sen University Cancer Center, RenJi Hospital
- Responsible party
- Principal investigator, Cun Wang, RenJi Hospital
- Investigators
- Cun Wang, Principal investigator, State Key Laboratory of Systems Medicine for Cancer, Shanghai Cancer Institute & Department of Liver Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632235
- Sponsor's protocol ID
- 2026-086-(1)
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No