Camrelizumab Combined With Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)
camrelizumab combined with rivoceranib and HAICcamerlizumab + rivoceranib
camrelizumab combined with rivoceranib and HAIC: systemic therapy combined with locoregional theraphy as conversion therapy
camerlizumab + rivoceranib: systemic therapy
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
R0 rate — 24 months R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
dual primary endpoint: EFS and OS — 36 months 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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