CTRI/2023/02/050126尚未招募2 期
Evaluation of low dose nivolumab with neoadjuvant chemotherapy in non small cell lung cancer - ELo
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18-75 years
- •2. Pathological diagnosis of NSCLC
- •3. Stage 2B or 3A disease
- •4. Being considered for neoadjuvant chemotherapy followed by surgery after discussion in MDT (Multi-disciplinary tumour board). Complete surgical removal should be deemed achievable including surgical fitness.
- •5. ECOG PS 0-1.
- •6. Adequate organ functions and marrow functions as described below
- •A. Serum creatinine <= 1.5 mg or creatinine clearance >=50 ml/min.
- •B. Serum Bilirubin < 1.5 UNL, AST/ALT < 3 UNL
- •C. Hb >10.0 gm/dl, Platelet counts >100 X109 /L, absolute neutrophil count > 1.5 X109/L
- •7. Able to understand the PIS (patient information sheet and give informed consent)
排除标准
- •1.ECOG PS >=2
- •2.Harbouring EGFR mutations, ALK and ROS1 rearrangements
- •3.Prior exposure to immune checkpoint inhibitors.
- •4.Pre-existing autoimmune condition requiring systemic immunosuppression including steroids ( >10 mg Prednisolone equivalent).
- •5.Acquired immunosuppression (HIV, systemic immunosuppression)
- •6.Haematopoietic or organ transplant recipient.
- •7.History of any other malignancy in past or synchronous malignancy
- •8.Pregnant and lactating mothers
- •9.Willing to afford or have access to immunotherapy outside study
- •10.Patients with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or compromise the patientâ??s ability to participate in this study.
研究者
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