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Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC

NCT04663035 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-03-22

No results posted yet for this study

Summary

This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.

Conditions

  • Recurrent Hepatocellular Carcinoma

Interventions

DRUG

Tislelizumab

200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months.

PROCEDURE

Ablation

After local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes).

Sponsors & Collaborators

  • Ming Zhao

    lead OTHER

Principal Investigators

  • Ming Zhao, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2023-12-18
Completion
2025-12-18

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 NCT04663035 on ClinicalTrials.gov