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

Last updated: May 27, 2025
Sponsor: Jiangxi Provincial Cancer Hospital
Overall Status: Completed

Phase

N/A

Condition

Carcinoma

Treatment

125I seed implantation

PD-1 Inhibitors

Clinical Study ID

NCT06991907
2025ky159
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1) Diagnosis of advanced primary hepatocellular carcinoma (HCC) according toestablished criteria [13]; (2) Presence of ≥1 measurable extrahepatic metastaticlesions; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0; (4) Barcelona Clinic Liver Cancer (BCLC) stage C; (5) Child-Pugh class A or B; (6) Platelet count > 75×10⁹/L; (7) Estimated life expectancy > 3 months; (8)Complete clinical data available.

Exclusion

Exclusion Criteria:

  • (1) Poor treatment compliance or inability to cooperate with ¹²⁵I seed implantationsurgery; (2) Unavoidable large bronchi or major blood vessels along the puncturepathway for seed implantation; (3) History of other primary malignant tumors (exceptcured non-melanoma skin cancer or in-situ carcinomas); (4) Severe cardiorenalinsufficiency (e.g., New York Heart Association class III/IV heart failure orestimated glomerular filtration rate < 30 mL/min/1.73m²); (5) Incomplete clinicaldata or loss to follow-up before the study endpoint.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: 125I seed implantation
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
March 20, 2025

Connect with a study center

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Site Not Available

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