TACE With Lenvatinib Versus Lenvatinib Alone in in First-line Treatment of Advanced HCC

• Status: Recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

1. Age 18-75 years old;

2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;

3. There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis;

4. ECOG score 0-1;

5. Child-Pugh class A;

6. Expected survival time ≥ 3 months;

7. Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

1. Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct;

2. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;

3. There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;

4. Brain metastases;

5. Hypersensitivity to intravenous contrast agents;

6. Pregnant or lactating women or subjects with family planning within two years;

7. With HIV, syphilis infection;

8. Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;

9. Allogeneic organ transplant recipients;

10. Severe dysfunction of heart and kidney or other organs;

11. Active severe infection > grade 2 (NCI-CTC version 4);

12. Suffering from mental and psychological diseases may affect informed consent;

13. Unable to take oral medication;

14. Participated in other drug clinical trials within 12 months before enrollment;