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

NCT06796803 | Recruiting Phase 2 DMC

• 2 other identifiers: MA-HCC-II/III-0262024ZD0520401
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 2

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.

Conditions

Potentially Resectable Hepatocellular Carcinoma

Keywords

conversion therapy; hepatocellular carcinoma; camrelizumab and rivoceranib

Outcome Measures

Primary Outcomes (2)

• R0 rate

  R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin

  24 months

• dual primary endpoint: EFS and OS

  Event-free survival (EFS), defined as the time from randomization to progression (RECIST v1.1), recurrence and death from any cause. Overall survival (OS) after randomization, defined as the time from randomization to death from any cause

  36 months

Secondary Outcomes (5)

• ORR

  24 months

• DCR

  24 months

• pCR rate

  24 months

• MPR rate

  24 months

• AE

  24 months

Study Arms (2)

camrelizumab + rivoceranib + HAIC

EXPERIMENTAL

Drug: camrelizumab combined with rivoceranib and HAIC

camrelizumab + rivoceranib

ACTIVE COMPARATOR

Drug: camerlizumab + rivoceranib

Interventions

camrelizumab combined with rivoceranib and HAIC DRUG

systemic therapy combined with locoregional theraphy as conversion therapy

camrelizumab + rivoceranib + HAIC

camerlizumab + rivoceranib DRUG

systemic therapy

camrelizumab + rivoceranib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of hepatic encephalopathy
• Diffuse HCC, intrahepatic tumor burden \> 50%
• PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
• Clinically significant ascites
• Prior allogeneic stem cell or solid organ transplantation

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Huichuan Sun, MD, PHD

CONTACT

sun.huichuan@zs-hospital.sh.cn; sun.huichuan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): February 28, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (2)