Intrahepatic CholangiocarcinomaPhase 2NCT07570849
Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, phase II clinical trial designed to evaluate the efficacy and safety of chidamide in combination with chemotherapy and immunotherapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 1 Jan 2029
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial procedures.
- Male or female, aged 18 to 75 years.
- Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory test values within 7 days prior to the start of treatment must meet the following criteria:
- Neutrophils ≥ 1.5 × 10⁹/L;
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- Platelets ≥ 50 × 10⁹/L;
- Hemoglobin ≥ 90 g/L (without packed red blood cell transfusion within the past 2 weeks);
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL/min;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Serum albumin ≥ 30 g/L;
- For patients not receiving anticoagulation therapy: INR or aPTT ≤ 1.5 × ULN. Patients receiving prophylactic anticoagulation are eligible if INR ≤ 2 × ULN and aPTT is within the normal range within 14 days prior to the start of study treatment;
- Serum bilirubin ≤ 1.25 × ULN.
- Life expectancy ≥ 12 weeks.
- Presence of at least one measurable lesion as confirmed by RECIST version 1.1.
- Patients with controlled hepatitis B are eligible if they meet the following criteria: HBV antiviral therapy must have been administered for at least 4 weeks, and HBV viral load must be less than 100 IU/mL prior to the first dose of study drug. Patients receiving anti-HBV treatment with a viral load below 100 IU/mL should maintain the same treatment throughout the study period. Patients who are positive for hepatitis B core antibody (HBcAb), negative for hepatitis B surface antigen (HBsAg), negative or positive for hepatitis B surface antibody (HBsAb), and have an HBV viral load below 100 IU/mL do not require prophylactic anti-HBV treatment.
- Patients must have good compliance.
Who cannot join
- 1. Prior treatment with a histone deacetylase (HDAC) inhibitor. 2. Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment within the past 2 years (i.e., use of corticosteroids or immunosuppressive medications). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- 3. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major surgery is defined as a procedure requiring at least 3 weeks of recovery time before study treatment can be administered.
- 4. Known history of interstitial lung disease or has non-infectious pneumonitis requiring corticosteroid treatment.
- 5. Known history of human immunodeficiency virus (HIV) infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or stem cell transplantation.
- 6. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, or other hepatitis; severe cirrhosis, fatty liver, hereditary liver disease, liver atrophy, portal hypertension, uncontrolled major seizure disorder, or superior vena cava syndrome.
- 7. Known history of allergy to macromolecular protein preparations/monoclonal antibodies or to the chemotherapeutic agents used in this trial.
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- 8. Participation in another clinical trial of an investigational drug within 4 weeks prior to the first dose of study drug (calculated from the last use of the investigational drug).
- 9. Receipt of a live vaccine within 30 days prior to the first dose of study drug. Inactivated virus vaccines for seasonal influenza are permitted; however, intranasally administered live attenuated influenza vaccines are not permitted.
- 10. Received prior local therapy to the liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug. Note: Patients must have evidence of disease progression after local therapy to be eligible.
- 11. Received prior radiotherapy to non-hepatic regions within 2 weeks prior to the first dose of study drug. Patients must have recovered from all radiotherapy-related toxicities, not require corticosteroids, and have no history of radiation pneumonitis. A 2-week washout period is permitted for palliative radiotherapy for non-central nervous system (CNS) disease (≤ 2 weeks of radiotherapy).
- 12. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical carcinoma in situ) that have undergone potentially curative therapy are permitted.
- 13. History of alcohol dependence, or history of drug abuse or substance abuse within the past 1 year.
- 14. Is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period, from the screening visit through 120 days after the last dose of study treatment.
- 15. Has any condition (e.g., disease history or evidence, treatment, laboratory abnormality) that, in the investigator's judgment, could interfere with the trial results, preclude the patient's full participation in the study, or for which participation in the study is not in the patient's best interest.
- 16. Patients deemed by the investigator to be unsuitable for participation in this trial for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Jian Zhou, professor, 0086-21-64041990, zhou.jian@zs-hospital.sh.cn
Zheng Wang, professor, 0086-21-64041990, wzdoc@163.com
About this study
Official title: Open-label, Phase II Clinical Study of Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
This is a single-center, open-label, phase II clinical trial designed to evaluate the efficacy and safety of chidamide in combination with chemotherapy and immunotherapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer.
The study will enroll approximately 35 patients with histologically or pathologically confirmed unresectable or metastatic ICC who have not received prior systemic therapy. All participants will receive chidamide, an oral HDAC inhibitor, in combination with gemcitabine, cisplatin, and an immune checkpoint inhibitor. Treatment will be administered in 21-day cycles until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Read more
The primary study endpoints are objective response rate (ORR), and safety, evaluated by the frequency and severity of adverse events. Secondary endpoints include progression-free survival (PFS), duration of response (DOR), overall survival (OS), and exploratory biomarker analyses.
The study aims to assess whether the addition of chidamide to standard chemotherapy and immunotherapy can improve treatment outcomes in this patient population.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitorDrug
Also called Chidamide + Gemcitabine + cisplatin + immune checkpoint inhibitor
Chidamide 20 mg orally, twice a week (biw), starting on Day 8 of each cycle. The interval between two doses should be no less than 3 days (i.e., on Days 8, 11, 15, and 18). Take 30 minutes after a meal.
PD-1 Monoclonal Antibody 200mg/240 mg diluted in 100 mL normal saline, administered as an intravenous infusion over 60 ± 5 minutes, every 3 weeks (q3w).
Gemcitabine Hydrochloride 1000 mg/m², intravenous infusion, administered on Days 1 and 8 of each cycle. Cisplatin 25 mg/m², intravenous infusion, administered on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide, Gemcitabine, cisplatin, PD-1 antibody | Experimental | Not described Receives: Drug: Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Defined as the percentage of patients who achieve complete response (CR) and partial response (PR) out of the total number of patients in the analysis set
Measured: Up to 2 years
Adverse Events
evaluated by the frequency and severity of adverse events
Measured: Up to 2 years
Secondary outcomes (3)
progression-free survival (PFS)
PFS assessed by investigator per RECIST v1.1, measured from the date of treatment until progression or death, whichever is first met
Measured: Up to 2 years
duration of response (DOR)
From the first date of response until the date of first documented progression according to RECIST 1.1
Measured: Up to 2 years
overall survival (OS)
From the first dose of treatment until the date of death from any cause
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570849
- Sponsor's protocol ID
- B2025-739R
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase II Clinical Study of Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07570849
- Acronym / sponsor ID
- B2025-739R
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 May 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 is a single-center, open-label, phase II clinical trial designed to evaluate the efficacy and safety of chidamide in combination with chemotherapy and immunotherapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer.
The study will enroll approximately 35 patients with histologically or pathologically confirmed unresectable or metastatic ICC who have not received prior systemic therapy. All participants will receive chidamide, an oral HDAC inhibitor, in combination with gemcitabine, cisplatin, and an immune checkpoint inhibitor. Treatment will be administered in 21-day cycles until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
The primary study endpoints are objective response rate (ORR), and safety, evaluated by the frequency and severity of adverse events. Secondary endpoints include progression-free survival (PFS), duration of response (DOR), overall survival (OS), and exploratory biomarker analyses.
The study aims to assess whether the addition of chidamide to standard chemotherapy and immunotherapy can improve treatment outcomes in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide, Gemcitabine, cisplatin, PD-1 antibody | Experimental | Drug: Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial procedures.
- Male or female, aged 18 to 75 years.
- Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory test values within 7 days prior to the start of treatment must meet the following criteria:
Key exclusion criteria (15 listed)
- 1. Prior treatment with a histone deacetylase (HDAC) inhibitor. 2. Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment within the past 2 years (i.e., use of corticosteroids or immunosuppressive medications). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- 3. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major surgery is defined as a procedure requiring at least 3 weeks of recovery time before study treatment can be administered.
- 4. Known history of interstitial lung disease or has non-infectious pneumonitis requiring corticosteroid treatment.
- 5. Known history of human immunodeficiency virus (HIV) infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or stem cell transplantation.
- 6. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, or other hepatitis; severe cirrhosis, fatty liver, hereditary liver disease, liver atrophy, portal hypertension, uncontrolled major seizure disorder, or superior vena cava syndrome.
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 |
|---|---|---|
| Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitorAlso: Chidamide + Gemcitabine + cisplatin + immune checkpoint inhibitorChidamide 20 mg orally, twice a week (biw), starting on Day 8 of each cycle. The interval between two doses should be no less than 3 days (i.e., on Days 8, 11, 15, and 18). Take 30 minutes after a meal. PD-1 Monoclonal Antibody 200mg/240 mg diluted in 100 mL normal saline, administered as an intravenous infusion over 60 ± 5 minutes, every 3 weeks (q3w). Gemcitabine Hydrochloride 1000 mg/m², intravenous infusion, administered on Days 1 and 8 of each cycle. Cisplatin 25 mg/m², intravenous infusion, administered on Day 1 of each cycle. | Drug | Chidamide, Gemcitabine, cisplatin, PD-1 antibody |
Primary outcome
objective response rate (ORR)
Time frame: Up to 2 years
Defined as the percentage of patients who achieve complete response (CR) and partial response (PR) out of the total number of patients in the analysis set
Adverse Events
Time frame: Up to 2 years
evaluated by the frequency and severity of adverse events
3 secondary outcomes
progression-free survival (PFS)
Time frame: Up to 2 years
duration of response (DOR)
Time frame: Up to 2 years
overall survival (OS)
Time frame: Up to 2 years
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 6 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Zhongshan Hospital at 1 site 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 17 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 6 May 2026.