Chidamide Combined With Benmelstobart, Nab-paclitaxel, and SBRT as Second-Line Treatment for Advanced BTC

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Study First Submitted
This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of chidamide combined with benmelstobart, nab-paclitaxel, and immunogenic radiotherapy (SBRT) as second-line treatment in patients with advanced biliary tract cancer (BTC). The study plans to enroll 41 BTC patients who have previously received first-line systemic therapy, and these patients will receive chidamide, benmelstobart, nab-paclitaxel, and SBRT. The primary endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), duration of response (DoR), overall survival (OS), and safety.
Trial Details
NCT Number NCT07890506
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Chipscreen Biosciences, Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions
(from sponsor)		 BTC
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov