NCT04699721进行中（未招募）2 期
Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable Non-small Cell Lung Cancer
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed previously untreated non-small cell lung cancer. Patients with stage II, IIIA and potentially resectable stage IIIB (T3N2) disease (according to AJCC 8th edition) are eligible ;
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- •18 years ≤ Age ≤ 80 years. Signed and dated written informed consent must be provided by the patient prior to admission to the study;
- •Patients with appropriate treatment compliance and could be followed-up correctly;
- •Patients with measurable or evaluable diseases (according to RECIST 1.1);
- •Patients must have the ability to swallow oral drugs;
- •Patients with adequate pulmonary function capable of tolerating the proposed lung resection (as determined by the surgeon);
- •Signed and dated written informed consent must be provided by the patient prior to admission to the study.
排除标准
- •Subjects with known ALK translocations or EGFR mutations.
- •Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
- •Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included. If you have any questions, please contact the trial team;
- •Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
- •Patients who are inability to follow the procedures required in the protocol due to any medical, mental or psychological conditions;
- •Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody or any other antibodies or drugs that target T cell costimulation or immune checkpoint pathways;
- •Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection;
- •Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome;
- •Patients with a history of allergy to study drugs or ingredients.
研究组 & 干预措施
Arm 1
Experimental
3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)
干预措施: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 (Drug)
结局指标
主要结局
Pathological complete response
时间窗: Within 3 days after the operation
The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review.
次要结局
- Objective response rate(28 days after the completion of three cycles of neoadjuvant therapy and before the operation)
- Major Pathologic Response(Within 3 days after the operation)
- Disease free survival(1 year, 3 years and 5 years after the operation)
- Recurrence rate(1 year, 3 years and 5 years after the operation)
- Overall survival(1 year, 3 years and 5 years after the operation)
- Adverse effects(Treatment-related adverse events were assessed between the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment.)
- Surgical complications (intra-operative and peri-operative)(90 days after the first medication or 30 days after the operation, whichever is later)
- R0 surgical events(28 days after the completion of three cycles of neoadjuvant therapy)
- Clinical TNM downstaging(28 days after the completion of three cycles of neoadjuvant therapy and before the operation)
研究者
研究点 (1)
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