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NCT06991907Completed

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

Efficacy and Safety of PD-1 Inhibitor Combined With 125I Seed Implantation in the Treatment of Extrahepatic Metastasis of Hepatocellular Carcinoma

Source: ClinicalTrials.gov · Last updated 28 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
80 (actual)
First submitted
25 Apr 2025
Start date
1 Jan 2020
Primary completion date
19 Mar 2025
Lead sponsor
Jiangxi Provincial Cancer Hospital
NCT number
NCT06991907

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 1 Jan 2020 to the primary completion date, 19 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • (1) Diagnosis of advanced primary hepatocellular carcinoma (HCC) according to established criteria \[13\]; (2) Presence of ≥1 measurable extrahepatic metastatic lesions; (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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jiangxi Cancer Hospital
Coordinator of this site? Confirm its status		NanchangChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.