HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma
brief summary
This is an open-label, single-arm, phase 2 study evaluating hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and cadonilimab as conversion therapy for initially unresectable hepatocellular carcinoma (HCC). The primary objective is to assess the conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Secondary objectives include curative-intent intervention rate, tumor response, survival outcomes, safety, pathological response, and exploratory tissue and blood biomarkers.
detailed description
Hepatocellular carcinoma is frequently diagnosed at an unresectable stage, and effective conversion strategies are needed to increase the chance of subsequent curative-intent treatment. This study is a prospective, open-label, single-arm, phase 2 trial evaluating HAIC-FOLFOX combined with lenvatinib and cadonilimab in participants with initially unresectable HCC.
Eligible participants will receive HAIC-FOLFOX every 3 weeks, lenvatinib orally once daily, and cadonilimab intravenously every 3 weeks. Tumor response and resectability will be evaluated during treatment by a multidisciplinary team (MDT). Curative-intent treatment includes R0 resection, curative ablation, or liver transplantation.
The primary endpoint is conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the MDT after study treatment. Secondary endpoints include the curative-intent intervention rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), time to progression (TTP), time to response (TTR), duration of response (DoR), safety, pathological complete response (pCR), major pathological response (MPR), and exploratory tissue and blood biomarkers. Participants will be followed for up to 2 years.
official title
A Prospective, Open-label, Single-arm, Phase 2 Study of Hepatic Arterial Infusion Chemotherapy Combined With Lenvatinib and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma