Adjuvant Tislelizumab Plus Lenvatinib for Patients at High-risk of HCC Recurrence After Curative Resection or Ablation

NCT05910970 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-23

No results posted yet for this study

Summary

Though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy is reported.

Conditions

Interventions

DRUG

Adjuvant tislelizumab plus lenvatinib

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC recurrence, or unacceptable adverse events.

DRUG

Adjuvant tislelizumab

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or unacceptable adverse events.

Sponsors & Collaborators

  • Guangxi Medical University

    lead OTHER

Principal Investigators

  • Jian-Hong Zhong, Ph.D · Guangxi Medical University Cancer Hospital

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
2024-02-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

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 NCT05910970 on ClinicalTrials.gov