NCT04542369招募中2 期
Neoadjuvant PD-1 Inhibitor (Tislelizumab) Plus Chemotherapy in Patients With Limited-stage Small-cell Lung Cancer: an Open-lable, Single-arm, Phase 2 Trial
Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年5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
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety: frequency of severe adverse events
研究概览
简要总结
This is a phase II, non-randomized, open-label, single-center study to evaluate the efficacy and safety of neoadjuvant PD-1 inhibitor (Tislelizumab) + chemotherapy (cisplatin/carboplatin + etoposide) followed by radical surgery and adjuvant Tislelizumab immunotherapy as first-line treatment in patients limited-stage SCLC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient shall sign the Informed Consent Form.
- •Aged 18 ≥ years.
- •Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage (local advanced) confirmed by imageological examinations.
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or
- •Life expectancy is at least 12 weeks.
- •At least 1 measurable lesion according to RECIST 1.
- •Patients with good function of other main organs (liver, kidney, blood system, etc.):
- •ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L#hemoglobin
- •the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN);
- •partial thromboplastin time (APTT) ≤1.5×ULN;
- •total bilirubin ≤1.5×ULN;
- •alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
- •No systemic metastasis;
- •Expected to be completely resected;
- •Good cardiopulmonary function and can tolerate surgical treatment;
- •Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Tislelizumab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
- •Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Tislelizumab (whichever is later).
排除标准
- •Participants who have received any systemic anti-cancer treatment for SCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
- •Participants with cancer other than SCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;
- •Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
- •With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- •Participants who are allergic to the test drug or any auxiliary materials;
- •Have or currently have interstitial lung disease;
- •Participants with active HIV;
- •Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
- •Pregnant or lactating women;
- •Any conditions of malabsorption;
- •Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- •Other factors that researchers think it is not suitable for enrollment.
研究组 & 干预措施
LS-SCLC
Experimental
Induction therapy: Tislelizumab 200mg, i.v., q3w, 4 cycles; cisplatin 75mg/m2, d1-3 or carboplatin AUC5, d1+ etoposide 100mg/m2, q3w, 4 cycles.
Regional therapy: Candidates for complete resection will receive surgery otherwise they will receive radiotherapy.
Adjuvant therapy: Patients received surgery will receive adjuvant Tislelizumab plus platinum-etoposide therapy for four cycles.
干预措施: Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) (Drug)
结局指标
主要结局
Safety: frequency of severe adverse events
时间窗: up to 18 months
The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
次要结局
- Progression-free survival (PFS)(up to 60 months)
- Overall survival (OS)(up to 63 months)
- Disease-free survival (DFS)(up to 60 months)
- Health related quality of life (HRQol)(up to 12 months)
- Objective response rate (ORR)(up to 4 months)
- Major pathologic response (MPR)(up to 5 months)
研究者
Peng Zhang
Director of science and education department
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
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