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

NCT ID: NCT06796803

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2030-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

camrelizumab + rivoceranib + HAIC

Group Type: EXPERIMENTAL

camrelizumab combined with rivoceranib and HAIC

Intervention Type: DRUG

systemic therapy combined with locoregional theraphy as conversion therapy

camrelizumab + rivoceranib

Group Type: ACTIVE_COMPARATOR

camerlizumab + rivoceranib

Intervention Type: DRUG

systemic therapy

Interventions

camrelizumab combined with rivoceranib and HAIC

systemic therapy combined with locoregional theraphy as conversion therapy

Intervention Type: DRUG

camerlizumab + rivoceranib

systemic therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form (ICF)

2. Aged ≥18 years and ≤75 years at time of signing ICF

3. Documented diagnosis of HCC confirmed by histology/cytology or clinically

4. 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

5. At least one measurable lesion (per RECIST v1.1) untreated lesion

6. ECOG performance status of 0 or 1

7. Child-Pugh ≤7 score

8. Life expectancy ≥12 weeks

9. Adequate organ function

10. No prior anti-tumor systemic therapies for HCC

Exclusion Criteria

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

2. Other active malignant tumor except HCC within 5 years or simultaneously

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

4. There is an absolute contraindication to HAIC

5. History of hepatic encephalopathy

6. Diffuse HCC, intrahepatic tumor burden > 50%

7. PVTT reaching the superior mesenteric vein, and bilateral PVTT are present

8. Clinically significant ascites

9. Prior allogeneic stem cell or solid organ transplantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Huichuan Sun, MD, PHD

Role: CONTACT

sun.huichuan@zs-hospital.sh.cn

sun.huichuan@zs-hospital.sh.cn

Other Identifiers

2024ZD0520401

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MA-HCC-II/III-026

Identifier Type: -

Identifier Source: org_study_id