Camrelizumab with Rivoceranib and HAIC as conversion therapy for potentially resectable liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized phase 2/3 trial evaluating the efficacy and safety of camrelizumab plus rivoceranib with hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for potentially resectable hepatocellular carcinoma. Participants are randomized to receive either camrelizumab plus rivoceranib plus HAIC or camrelizumab plus rivoceranib alone, with up to six HAIC cycles in the combination arm. Tumor response will be monitored by CT/MRI using RECIST v1.1, and patients achieving CR/PR or SD deemed suitable for curative resection may undergo surgery with curative intent. Postoperative therapy with camrelizumab plus rivoceranib is recommended to start 4–6 weeks after surgery once recovery allows. The control arm continues systemic therapy until progression or unacceptable toxicity.

Why it matters

Who can join: the full rules

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. Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry
6. At least one measurable lesion (per RECIST v1.1) untreated lesion
7. ECOG performance status of 0 or 1
8. Child-Pugh ≤7 score
9. Life expectancy ≥12 weeks
10. Adequate organ function
11. 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

Where it's running

• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Huichuan Sun, MD, PHD
• Email: sun.huichuan@zs-hospital.sh.cn
• Phone: sun.huichuan@zs-hospital.sh.cn

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.