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

Last updated: February 6, 2025
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Carcinoma

Treatment

camerlizumab+apatinib

camrelizumab combined with rivoceranib and HAIC

camrelizumab combined with apatinib and HAIC

Clinical Study ID

NCT06796803
MA-HCC-II/III-026
2024ZD0520401
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepaticmetastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumorsin one lobe are present alongside a single tumor with diameter ≤5 cm or up to threetumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving thecontralateral liver lobe or reaching the superior mesenteric vein. And no tumorthrombus 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

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

Study Design

Total Participants: 398
Treatment Group(s): 4
Primary Treatment: camerlizumab+apatinib
Phase: 2/3
Study Start date:
February 20, 2025
Estimated Completion Date:
February 28, 2030

Study 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.

Connect with a study center

  • Zhongshan Hospital

    Shanghai, Shanghai 200000
    China

    Site Not Available

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