NCT06796803

Camrelizumab Combined with Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) As Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)

Camrelizumab and Rivoceranib Plus HAIC As Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy. Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.

Conditions

• Potentially Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	camrelizumab combined with rivoceranib and HAIC	systemic therapy combined with locoregional theraphy as conversion therapy
DRUG	camerlizumab + rivoceranib	systemic therapy

Timeline

• Start date: 2025-02-20
• Primary completion: 2028-02-20
• Completion: 2030-02-28
• First posted: 2025-01-28
• Last updated: 2025-02-10

Locations

1 site across 1 country: China