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

NCT06796803

RecruitingPhase 2, Phase 3

Sponsor: Shanghai Zhongshan Hospital

Conditions: Potentially Resectable Hepatocellular Carcinoma

Interventions: camrelizumab combined with rivoceranib and HAIC, camerlizumab + rivoceranib

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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. 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

Locations (2)

Harbin, Heilongjiang, China
Shanghai, Shanghai Municipality, China