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The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma

NCT04997850 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-08-29

No results posted yet for this study

Summary

We adopted the prospective cohort study to compare the safety and efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody in the treatment of advanced unresectable liver cancer.The purposes of our study include：1. Primary objective: To compare the safety and efficacy of TACE combined with Lenvatinib and PD-1 antibody versus TACE alone in the conversion-resection of patients with advanced unresectable hepatocellular carcinoma.2. Secondary objective: To compare the long-term outcome of TACE combined with Lenvatinib and PD-1 antibody versus TACE alone for patients with advanced unresectable hepatocellular carcinoma.

Conditions

  • Hepatocellular Carcinoma Non-resectable
  • Transarterial Chemoembolization
  • Tyrosine Kinase Inhibitor
  • Immune Checkpoint Blockade

Interventions

DRUG

lenvatinib + sindilimab/carrelizumab

4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next treatment cycle was carried out. The trial was terminated if the drug was stopped for more than 28 days due to adverse drug reactions or other reasons. Patients with PD after 6 cycles of sindilimab/carrelizumab treatment were terminated. The follow-up treatment was based on the principle of individualization, multidisciplinary discussion and patients' willingness.

PROCEDURE

TACE

TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2018 Edition). The patients with HCC were selected according to the inclusion criteria (referring to the conditions of the subjects). The subjects who met the inclusion criteria could enter the study after they signed the informed consent. 4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next cycle of TACE treatment was carried out. The general principle is to reduce the number of interventional treatment and extend the interval of interventional operation as far as possible under the condition of controlling the tumor and the survival of patients with tumor.

Sponsors & Collaborators

  • Xinrui Zhu，MD

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-05-24
Completion
2024-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997850 on ClinicalTrials.gov