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

NCT ID: NCT06991907

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-03-20

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.

Conditions

HCC - Hepatocellular Carcinoma; 125I Seeds Implantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 inhibitor combined with 125I seed implantation group (combination therapy group)

The combination therapy group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy (selected based on individual patient assessment and shared decision-making) alongside 125I radioactive seed implantation targeting their extrahepatic metastatic lesions. The intervention involves percutaneous implantation of 125I seeds into accessible metastases under imaging guidance to deliver localized radiation, complemented by systemic PD-1 inhibitor administration according to standard protocols. Patients undergo regular follow-ups to monitor treatment response (e.g., tumor size, pain scores), assess safety through laboratory and imaging evaluations, and manage comorbidities (such as hepatitis B virus infection or treatment-related adverse events) to ensure personalized, comprehensive care throughout the treatment course.

Group Type: ACTIVE_COMPARATOR

125I seed implantation

Intervention Type: PROCEDURE

125I seed implantation

PD-1 Inhibitors

Intervention Type: DRUG

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.

PD-1 inhibitor monotherapy group (PD-1 single-agent group)

The PD-1 single-agent group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy selected through shared decision-making based on their individual clinical status, tumor characteristics, and treatment preferences. The intervention involves systemic administration of PD-1 inhibitors (e.g., pembrolizumab, nivolumab) according to standard oncological protocols, with dose and treatment schedule tailored to guidelines and patient tolerance. Patients in this group undergo regular follow-ups to assess treatment response (e.g., tumor progression via imaging, serum AFP levels), monitor safety through laboratory evaluations (blood counts, liver/kidney function), and manage comorbidities-such as chronic hepatitis B virus infection requiring antiviral prophylaxis or immune-related adverse events (e.g., pneumonitis, colitis)-to ensure safe and effective care throughout the treatment course.

Group Type: SHAM_COMPARATOR

PD-1 Inhibitors

Intervention Type: DRUG

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.

Interventions

125I seed implantation

125I seed implantation

Intervention Type: PROCEDURE

PD-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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

2025ky159

Identifier Type: -

Identifier Source: org_study_id