TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• 1) Age 18-70 years old, gender is not limited.

• 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).

• 3)Patients must have at least one tumor lesion that can be accurately measured.

• 4)Conform to any of the following criteria (1) multiple nodules >3; (2) ≥2 nodules, any of which is >3 cm; (3) invasion of the portal vein or hepatic vein.

• 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group

• 6)No previous anti-HCC treatment.

• 7)Eastern Co-operative Group performance status 2 or less.

• 8)Liver function: Child's A or B (score < 7).

Exclusion Criteria:

• 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava;

• 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs;

• 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months