HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma
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
Tongji Hospital
36 participants
Dec 30, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Administration of oxaliplatin, leucovorin, and fluorouracil via the tumor-feeding hepatic artery every 3 weeks.
Lenvatinib administered orally once daily at 8 mg for participants weighing ≤60 kg or 12 mg for participants weighing \>60 kg.
Cadonilimab administered intravenously at 10 mg/kg every 3 weeks.
Locations(1)
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NCT06187961