125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer
ConditionOligometastatic Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Min
About this trial
Most patients with metastatic cancer eventually develop resistance to systemic therapy. A subset of patients experience oligoprogression, characterized by progression at a limited number of lesions while other disease sites remain controlled by ongoing systemic therapy. This randomized phase 2 trial evaluates whether image-guided 125I seed implantation targeting all oligoprogressive extracranial lesions, combined with standard-of-care systemic therapy, improves progression-free survival compared with standard-of-care systemic therapy alone in patients with metastatic NSCLC or CRC.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).
Presence of metastatic disease with extracranial oligoprogression, defined as progression in up to five (≤5) individual lesions on CT or PET/CT imaging, while other known disease sites remain stable or controlled.
Received at least one prior line of standard systemic anticancer therapy, including maintenance therapy, for metastatic disease.
Disqualifiers
Pregnancy or breastfeeding.
Leptomeningeal disease or diffuse central nervous system involvement. Uncontrolled infection or serious medical comorbidities that, in the investigator's judgment, would preclude safe participation or interventional procedures.
Prior radiotherapy or brachytherapy requiring re-irradiation to the same tumor location planned for 125I seed implantation.
Known bleeding diathesis or uncorrectable coagulation disorders contraindicating interventional procedures.
Trial design
Treatments tested in this trial
- Standard-of-Care Systemic Therapy
- 125I Seed Implantation
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Li Min
Lead sponsor
Jinan Military General Hospital
Sponsor institution
Source ClinicalTrials.gov