Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients Without Progression After First-line Chemotherapy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV NSCLC patients.
详细描述
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy，and to observe the abscopal effect, whether the scheme can improve PFS and OS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
- •Patients who were oligometastasis evaluated by PET-CT or other examinations after first-line chemotherapy. Eligible patients should have 2 to 5 distant metastases (at least 2 metastases were suitable for low fractionated radiotherapy). At least one distant measurable lesion outside the radiation sites.
- •Age varied from 18 to 75 years old.
- •ECOG performance status 0-
- •Expected lifespan ≥3 months.
- •Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
- •Able to understand and give written informed consent and comply with study procedures.
- •Exclusion criteria
- •Allergy of rhGM-CSF and its accessories.
- •Disease of systemic immune or immune disorders.
- •Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
- •Patients with thrombotic disease or platelets ≥600×109/L
- •Cancer history within 5 years apart from NSCLC before enrollment.
- •Tumor related immunotherapy within 4 weeks, including but not limited to immune cell therapy, tumor vaccine therapy, Immune checkpoint therapy, and other immunomodulators (such as thymosin, lentinan) except for rhGM-CSF.
- •The abnormality of kidney , heart or lung functions（serum creatinine, Cr>177mol/L; serum AST or ALT more than 2 times above normal limits; total bilirubin, TBIL>34mol/L）.
- •HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections.
- •Women in pregnancy or lactation.
- •Others who do not meet the inclusion criteria.
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be> 4Gy per time（or BED >45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
干预措施: rhGM-CSF (Biological)
Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be> 4Gy per time（or BED >45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
干预措施: Pemetrexed (Drug)
Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be> 4Gy per time（or BED >45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
干预措施: Local Radiotherapy (Radiation)
Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be> 4Gy per time（or BED >45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
干预措施: Single agent (Drug)
Single agent maintenance therapy
Maintenance treatment by single agent in a cycle of 21 days.
干预措施: Single agent (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
Progression-Free-Survival
次要结局
- Abscopal effect rate(At the time point of 4 weeks after completion of rhGM-CSF)
- OS(2 years)
研究者
Jinming Yu
chief physician
Shandong Cancer Hospital and Institute