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NCT06991907

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

Completed NA Last updated 28 May 2025
What this trial tests

NA trial testing 125I seed implantation in HCC - Hepatocellular Carcinoma in 80 participants. Completed in 20 March 2025.

Timeline
1 January 2020
Primary endpoint
19 March 2025
20 March 2025

Quick facts

Lead sponsorJiangxi Provincial Cancer Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date1 January 2020
Primary completion19 March 2025
Estimated completion20 March 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangxi Provincial Cancer Hospital

Who can join

Adults 18 to 80, any sex, with HCC - Hepatocellular Carcinoma or 125I Seeds Implantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The efficacy and safety of PD-1 inhibitors combined with <sup>125</sup>I seed implantation in treating extrahepatic metastasis of hepatocellular carcinoma.
    Tang X, Liu Y, Chen L, Tan L, et al · · 2025 · PMID 41357510 · DOI 10.3389/fmed.2025.1693447

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Other recruiting trials for HCC - Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Jiangxi Provincial Cancer Hospital trials

Trials by the same sponsor.

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Data sources for this page

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