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Ablation Combined With PD-1 in HCC: Phase II Study

NCT04652440 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-19

No results posted yet for this study

Summary

This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with HCC and the exploratory study objective to evaluate the effect of ablation combined with PD-1 monoclonal antibody on immune function and hepatitis virus infection status in patients with HCC. This study will be divided into two stages, and the first stage is to enroll 6 patients for dose-limited toxicity (DLT) observation. If DLT appeared in \< 2 patients, the second stage was entered and the other 24 patients were further enrolled.

Conditions

Interventions

DRUG

PD-1 monoclonal antibody

The enrolled patients received intravenous injections of PD-1 monoclonal antibody (Tislelizumab 200mg) on the 1 day before radiofrequency or microwave ablation treatment, and 21(±7) days, 42(+7) and 63(+7) after ablation.

PROCEDURE

Radiofequencey or microwave ablation

The enrolled patients received primary radiofrequency or microwave ablation on the day after the first dose of PD-1 antibody treatment.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04652440 on ClinicalTrials.gov