NCT05985798 Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC
| NCT ID | NCT05985798 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-07-31 |
Trial Parameters
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Brief Summary
This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria: * Advanced HCC (BCLC stage C) with diagnosis confirmed pathologically or clinically * Disease amenable to TACE * No prior systemic therapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC * Child-Pugh class A * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Life expectancy of at least 3 months * At least one measurable intrahepatic lesion * Adequate organ and hematologic function * Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^2 IU/mL * Patients with hepatitis C need to finish the anti-HCV treatment Exclusion Criteria: * Tumor thrombus involving main portal vein or both the first left and right branch of portal vein * Vena cava invasion * Central nervous system metastasis * History of hepatic encephalopathy * History of organ and cell transplant
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