Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advance
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 approximatel
| Condition(s) | Intrahepatic Cholangiocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. 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 |
| Who can participate | Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial procedures. 2. Male or female, aged 18 to 75 years. 3. Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Laboratory test values within 7 days prior to the start of treatment must meet the following criteria: 1. Neutrophils ≥ 1.5 × 10⁹/L; 2. Platelets ≥ 50 × 10⁹/L; 3. Hemoglobin ≥ 90 g/L (without packed red blood cell transfusion within the past 2 weeks); 4. Serum creatinine ≤ 1.5 × up |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Zhongshan Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-03-01 |
| NCT ID | NCT07570849 |
| Official listing | https://clinicaltrials.gov/study/NCT07570849 |