drugset / Trial / NCT06991907

PD-1 Inhibitor Combined With 125I Seed Implantation for Hepatocellular Carcinoma's Extrahepatic Metastasis: Efficacy and Safety

NCT06991907

Completed 80 enrolled Jiangxi Provincial Cancer Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study aims to explore the effectiveness and safety of 125I seed implantation in the treatment of hepatocellular carcinoma (HCC) with extrahepatic metastases, and to compare the efficacy differences between PD-1 inhibitor monotherapy and the combination of PD-1 inhibitor and 125I seed implantation. A retrospective analysis was conducted on 80 eligible patients admitted to Jiangxi Provincial Cancer Hospital from January 2018 to March 2025, with 40 patients in each group. Data including patients' basic characteristics, tumor staging, alpha-fetoprotein (AFP) levels, history of hepatitis B virus (HBV) infection, etc., were collected. Parameters of seed implantation and details of metastatic lesions were recorded. Through regular follow-ups after treatment, the degree of pain relief (evaluated by Visual Analogue Scale, VAS), tumor control efficacy (response rate, RR; local control rate, LCR), survival outcomes (local progression-free survival, LPFS; progression-free survival, PFS; overall survival, OS) were assessed. Additionally, indicators such as blood cell analysis, liver and kidney function, and treatment-related adverse reactions were monitored, providing a clinical basis for optimizing comprehensive treatment regimens for HCC with extrahepatic metastases.

Timeline

Start
2020-01-01
Primary completion
2025-03-19
Completion
2025-03-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Camrelizumab Monoclonal antibody 200 mg Intravenous
Comparator Sintilimab Monoclonal antibody 200 mg Intravenous
Comparator Toripalimab Monoclonal antibody 200 mg Intravenous