Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
This is a prospective, open-label, randomized phase 2 controlled trial enrolling adults with histologically confirmed metastatic NSCLC or colorectal cancer who developed extracranial oligoprogression (≤5 progressive lesions) on PET/CT or CT while receiving at least first-line systemic therapy (including maintenance). Eligible patients will be randomized 1:1 to (1) standard-of-care systemic therapy per treating physician discretion, or (2) image-guided 125I seed implantation to all oligoprogressive lesions plus standard-of-care systemic therapy.
Oligoprogression will be determined by predefined imaging response criteria (RECIST and/or PERCIST, depending on baseline imaging modality), with confirmation by designated study radiologists. Follow-up imaging will be performed at 8 weeks (±2 weeks) after randomization and every 12 weeks (±2 weeks) thereafter to assess disease status. The primary endpoint is progression-free survival measured up to 12 months. Secondary endpoints include overall survival, time to initiation of a new systemic therapy, local control of implanted lesions, safety, and quality of life. Optional exploratory objectives may include circulating tumor DNA dynamics and metabolic PET parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •All oligoprogressive lesions are technically feasible and considered safe for image-guided 125I seed implantation, as determined by the treating interventional team.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ function to undergo interventional procedures and systemic therapy, per institutional standards.
- •Ability to understand and willingness to sign written informed consent.
排除标准
- •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.
- •Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From randomization up to 12 months
Progression-free survival is defined as the time from randomization to systemic 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.
次要结局
- Time to Initiation of a New Systemic Therapy (TTNT)(From randomization up to 12 months)
- Local Control of Treated Lesions(From intervention to 12 months after randomization)
- Overall Survival (OS)(From randomization up to 24 months)
- Time to Initiation of a New Systemic Therapy (TTNT)(From randomization up to 12 months)
- Local Control of Treated Lesions(From intervention to 12 months after randomization)
- Safety and Treatment-Related Adverse Events(From intervention through 12 months)
研究者
Li Min
Vice Director
Jinan Military General Hospital