Actively Recruiting
Open-label Phase II Study of Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2026-05-06
35
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of chidamide with chemotherapy and immunotherapy as a first treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer. This phase II, open-label trial aims to assess the safety and effectiveness of this combination in patients who have unresectable or metastatic ICC and no prior systemic therapy. The study is sponsored by Shanghai Zhongshan Hospital and seeks to improve treatment outcomes for this patient group. Participants will receive treatment cycles every 21 days that include oral chidamide taken twice a week starting on Day 8, intravenous gemcitabine on Days 1 and 8, cisplatin on Day 1, and an immune checkpoint inhibitor administered by intravenous infusion every three weeks. Treatment will continue until disease progression, unacceptable side effects, or withdrawal from the study. The trial will enroll about 35 patients and monitor them through this regimen. Participants will undergo regular assessments including tumor response evaluations, safety monitoring for adverse events, and laboratory tests. Researchers will measure outcomes such as objective response rate, progression-free survival, duration of response, and overall survival over up to two years. The study also includes exploratory biomarker analyses and requires patients to maintain compliance and attend scheduled visits throughout the trial period.
CONDITIONS
Brief Title
Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to comply with study procedures
- Male or female aged 18 to 75 years
- Histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Laboratory values within 7 days before treatment meeting specific blood counts, liver and kidney function criteria
- Life expectancy of at least 12 weeks
- At least one measurable lesion according to RECIST version 1.1
- Controlled hepatitis B infection meeting specific viral load and treatment requirements
- Good compliance with study requirements
You will not qualify if you...
- Prior treatment with a histone deacetylase (HDAC) inhibitor
- Active autoimmune disease requiring systemic treatment in past 2 years (except psoriasis)
- Planned major surgery during the study or screening period
- History of interstitial lung disease or non-infectious pneumonitis needing corticosteroids
- Known HIV infection, immunodeficiency disorders, or history of organ/stem cell transplantation
- Significant liver disease including active viral hepatitis, severe cirrhosis, or portal hypertension
- Allergy to study drugs including monoclonal antibodies or chemotherapeutic agents
- Participation in another investigational drug trial within 4 weeks prior to study
- Receipt of live vaccine within 30 days prior to study drug
- Prior local liver therapy within 4 weeks before study drug with disease progression
- Prior radiotherapy to non-hepatic regions within 2 weeks before study drug
- Additional malignancy requiring treatment in past 3 years, except certain skin or in situ cancers
- History of alcohol, drug, or substance abuse within 1 year
- Pregnant or breastfeeding or planning pregnancy during study and 120 days after last dose
- Any condition that may interfere with study participation or results as judged by investigator
- Investigator deems patient unsuitable for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive Chidamide combined with chemotherapy (Gemcitabine and Cisplatin) and immunotherapy (PD-1 antibody) as first-line treatment for advanced intrahepatic cholangiocarcinoma.
Visits every 3 weeks for administration of chemotherapy and immunotherapy; Chidamide taken orally twice a week starting Day 8 of each cycle
Trial Site Locations
Total: 1 location
1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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