TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study

Who is this study for? Patients with potentially high recurrence risk after liver cancer resection
What treatments are being studied? TACE/HAIC+Lenvatinib+Sintilimab
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Third Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Time Frame
Start Date: 2022-05-30
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 90
Treatments
Experimental: TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
Active_comparator: Direct surgery group
After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed.
Authors
Yang Yang, Hua Li
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov