Overview

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

Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency 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 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Antibodies
Antibodies, Monoclonal