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

Last updated: October 11, 2023
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Digestive System Neoplasms

Abdominal Cancer

Cancer/tumors

Treatment

Lenvatinib

liver resection

Sintilimab

Clinical Study ID

NCT05250843
LHuanxian
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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 theEuropean 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 andtreatment of primary liver cancer, one-stage liver cancer resection is feasible afterevaluation 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

Exclusion Criteria:

  • 1)Patients with definite tumor thrombus and distant metastasis in the main portal veinand inferior vena cava;
    1. Allergy to the components of intervention-related drugs such as lipiodol andchemotherapeutic drugs;
    1. Local treatment (including intervention, surgery, ablation, etc.) and systemictreatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) forliver cancer within the past 2 months

Study Design

Total Participants: 90
Treatment Group(s): 4
Primary Treatment: Lenvatinib
Phase: 2/3
Study Start date:
May 30, 2022
Estimated Completion Date:
December 30, 2024

Study Description

For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.

Connect with a study center

  • Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

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