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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 9, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07847710). This is a study registration, not published results. Lead sponsor: The First Affiliated Hospital with Nanjing Medical University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 81 participants (ESTIMATED). Conditions: Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy. Interventions: DRUG: Rilvegostomig Alpha; DRUG: Famitinib malate; DRUG: Gemcitabine & oxaliplatin; DRUG: Capecitabine; DRUG: S-1; PROCEDURE: hepatic arterial infusion chemotherapy (HAIC). Primary outcome measures: Event-free survival (EFS) , From the start of treatment until the first EFS event, assessed up to 36 months.. Brief summary: This is a multicenter, single-arm, exploratory clinical study for adults with locally advanced intrahepatic cholangiocarcinoma (ICC) that may be technically resectable but is difficult to remove directly by surgery. The study will evaluate whether perioperative treatment with Retlirafusp alfa, famitinib malate, and hepatic arterial infusion chemotherapy using gemcitabine and oxaliplatin (HAIC-GEMOX) can help control the tumor before surgery and support further treatment after surgery. Participants who meet the study requirements will receive neoadjuvant treatment before surgery. After surgery, participants will receive adjuvant treatment with Retlirafusp alfa combined with capecitabine or S-1. The study treatment and follow-up will continue until disease progression, unacceptable side effects, death, withdrawal of consent, or other protocol-defined stopping criteria. The main purpose of the study is to evaluate event-free survival. The study will also monitor tumor response, surgery-related outcomes, survival, and safety. Participants will have regular safety visits, blood tests, imaging examinations, and follow-up visits during and after treatment.