Phase II Study of Chidamide With Chemotherapy and Immunotherapy as First Treatment for Advanced Intrahepatic Cholangiocarcinoma

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.

Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma