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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

Other active malignant tumor except HCC within 5 years or simultaneously

Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)

There is an absolute contraindication to HAIC

Trial design

Treatments tested in this trial

  • camrelizumab combined with rivoceranib and HAIC
  • camerlizumab + rivoceranib

Treatment groups

398 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator