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Image-Guided 125I Seed Implantation Plus Standard Systemic Therapy for Patients With Multiple Metastatic Lesions
Sponsor: Li Min
Summary
Patients with more than five and up to ten metastatic lesions often have limited tolerance for surgery, radiotherapy, or thermal ablation because of cumulative treatment burden or expected toxicity. In this setting, systemic therapy alone frequently remains the primary treatment option. This prospective, open-label, randomized phase 2 study evaluates whether image-guided iodine-125 (125I) seed implantation, when added to standard-of-care systemic therapy, can improve disease control compared with standard systemic therapy alone in patients with multiple metastatic lesions. Clinical outcomes including progression-free survival, overall survival, safety, and quality of life will be prospectively assessed.
Official title: Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Multiple (6-10) Metastatic Lesions: A Randomized Phase 2 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01
Completion Date
2028-01-01
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Standard-of-Care Systemic Therapy
Systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy.
Iodine-125 (125I) Seed Implantation
Image-guided implantation of iodine-125 (125I) radioactive seeds to multiple metastatic lesions for local tumor control, performed under CT guidance (with PET/CT fusion planning when clinically indicated) according to institutional standards.
Locations (1)
The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, China