An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Radiological response (according to RECIST criteria)
研究概览
简要总结
Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.
详细描述
This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent document.
- •Age 18 and older.
- •Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- •Progressive disease after multiple-lines treatment.
- •Completion of entry into 68Ga-FAPI-46 study and completion of scan. The tumor lesions showing increased radiotracer uptake on 68Ga-FAPI-46 PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of metastatic lesions).
- •Able to remain motionless for up to 30-60 minutes per scan.
排除标准
- •Serum creatinine level >150 μmol/L.
- •Hemoglobin level <8.0 g/dL; white-cell count < 2.0×109/L; platelet count < 50×109/L; total bilirubin level >3 times the upper limit of the normal range and serum albumin level <2.0 g/dL.
- •Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- •Participants with severe allergy, or hypersensitivity to radiographic contrast material.
- •Participants with claustrophobia.
- •Pregnant or lactating women.
研究组 & 干预措施
177Lu-DOTA-EB-FAPI
177Lu-DOTA-EB-FAPI A maximum of 4 cycles of 90 mCi (3.3 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks
干预措施: 177Lu-DOTA-EB-FAPI radionuclide therapy (Drug)
结局指标
主要结局
Radiological response (according to RECIST criteria)
时间窗: 6 weeks, 12 weeks, 18 weeks, or up to 6 months
RECIST objective response after completion of radioligand therapy, which was defined by response category between baseline and restaging after RLT. Disease control after RLT was defined as either complete response (CR), partial response (PR), or stable disease (SD). Disease control rate (DCR) was reported as the proportion of patients with disease control after RLT.
次要结局
- Progression-free survival (PFS) and overall survival (OS)(disease progression, death or last follow-up conducted for all patients at the end of August 2024.)
- Dosimetry(6 weeks)