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.
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.
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.
Single group
Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor
DrugChidamide 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.
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
Adverse Events
evaluated by the frequency and severity of adverse events
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
duration of response (DOR)
From the first date of response until the date of first documented progression according to RECIST 1.1
overall survival (OS)
From the first dose of treatment until the date of death from any cause
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