NCT05608200 Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
| NCT ID | NCT05608200 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 427 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2026-10-31 |
Trial Parameters
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Brief Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria: * Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically * Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included * At least one measurable intrahepatic target lesion * Child-Pugh class A/B * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months Exclusion Criteria: * Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels * Vascular invasion involving inferior vena cava * Central nervous system metastasis * Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC * History of organ and cell transplantation * History of bleeding from esophageal and gastric varices
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