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.
Age ≥ 18 years.
Histologically or cytologically confirmed malignant solid tumor with metastatic disease.
Presence of more than five and up to ten (6-10) extracranial metastatic lesions, identified on CT or PET/CT imaging and assessable by RECIST version 1.1 (and/or PERCIST when PET imaging is used).
At least one metastatic lesion considered suitable for image-guided iodine-125 (125I) seed implantation according to institutional assessment.
Diffuse or unstable central nervous system involvement, including leptomeningeal disease or uncontrolled/symptomatic brain metastases requiring immediate local intervention.
Medical conditions that preclude safe interventional procedures, including uncontrolled infection, severe cardiopulmonary dysfunction, or other serious systemic illness, as judged by the investigator.
Contraindications to percutaneous implantation, such as uncorrectable coagulation disorders, high bleeding risk, lack of a safe needle path, or unacceptable risk to critical organs.
Pregnancy or breastfeeding.
Parallel
Standard-of-Care Systemic Therapy
Other interventionSystemic 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
Procedure/SurgeryImage-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.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 and/or PERCIST criteria, based on the baseline imaging modality.
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Time to Initiation of a New Systemic Therapy (TTNT)
Time to initiation of a new systemic therapy is defined as the time from randomization to the start of a new line or regimen of systemic anticancer therapy due to disease progression or clinical decision.
Local Control of Treated Lesions
Local control is defined as the absence of in-field progression of metastatic lesions treated with iodine-125 (125I) seed implantation on follow-up imaging.
Safety and Treatment-Related Adverse Events
Incidence and severity of adverse events, including procedure-related toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Patterns of Disease Progression
Patterns of disease progression will be descriptively analyzed, including the development of new metastatic lesions versus progression of pre-existing lesions, based on radiographic and/or clinical assessment at the time of disease progression.
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Li Min
Lead sponsor
Jinan Military General Hospital
Sponsor institution
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