Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study
The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
• Signed Informed Consent Form (ICF)
• Aged ≥18 years and ≤75 years at time of signing ICF
• Documented diagnosis of HCC confirmed by histology/cytology or clinically
• Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
• Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry
• At least one measurable lesion (per RECIST v1.1) untreated lesion
• ECOG performance status of 0 or 1
• Child-Pugh ≤7 score
• Life expectancy ≥12 weeks
⁃ Adequate organ function
⁃ No prior anti-tumor systemic therapies for HCC