125I Seeds Implantation, HCC - Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, 125I Seed Implantation, PD-1 Inhibitors, Efficacy
Brief 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.
Interventions
PROCEDURE125I seed implantation
125I seed implantation
DRUGPD-1 Inhibitors
PD-1 inhibitors (sintilimab/teriprizumab/camrelizumab) are administered intravenously at a dose of 200 mg once every three weeks. According to the manufacturer's guidelines, the dose is reduced or discontinued based on the severity of adverse effects.
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression - free Survival (PFS) | Eligible patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow-up was measured from treatment start to first progression/death, with survival cutoff in Apr 2025 (max 62 months). | It is the time interval from the start of treatment (initiation of PD - 1 inhibitor therapy or combination treatment) to the occurrence of tumor progression (defined by imaging criteria such as RECIST) or death from any cause, whichever comes first. Tumor progression includes the development of new lesions, increase in the size of existing lesions, or clinical deterioration indicative of disease advancement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow - up measured from treatment start to death, with survival cutoff in Apr 2025 (max 62 months）. | The length of time from either the start of treatment or diagnosis until the death of the patient from any cause. |
Countries
China
Outcome results
None listed