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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2026-086-(1)
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, Wuhan TongJi Hospital, Sun Yat-Sen University Cancer Center, RenJi Hospital
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin | Experimental | Drug: Celecoxib + Pembrolizumab + Gemcitabine/CisplatinParticipants 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. |
| Active Comparator: Pembrolizumab + Gemcitabine/Cisplatin | Active comparator | Drug: Pembrolizumab + Gemcitabine/CisplatinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib + Pembrolizumab + Gemcitabine/CisplatinCelecoxib 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. | Drug | Experimental: Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin |
| Pembrolizumab + Gemcitabine/CisplatinPembrolizumab 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. | Drug | Active Comparator: Pembrolizumab + Gemcitabine/Cisplatin |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 24 months
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.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 36 months
Duration of Response (DoR)
Time frame: Up to 24 months
Safety and Tolerability
Time frame: From first dose until 30 days after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiyan Hu contact
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cun Wang (86 18160747569, 18160747569@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.