Director of Shandong Cancer Hospital and Institute
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 主要终点
- Number of participants experiencing adverse event (AE)
研究概览
简要总结
This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.
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
- •Subjects voluntarily participate in this study and sign informed consent.
- •NSCLC in stage IV.
- •No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
- •Previously received more than 1 chemotherapy regimen and progressed/ recurred.
- •At least one lesion is suitable for hypofraction radiotherapy.
- •There is at least one measurable lesion.
- •18 to 75 years old
- •The function of vital organs meets the following requirements. ANC ≥ 1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min#
- •The estimated survival period is more than 3 months.
- •Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment
排除标准
- •The subjects had any history of autoimmune disease or active autoimmune disease.
- •Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
- •Subjects with severe allergic reactions to other monoclonal antibodies.
- •The subjects had a central nervous system metastases of clinical symptoms.
- •Central squamous cell lung carcinoma.
- •Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
- •Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
- •Failing to properly control the clinical symptoms or disease of the heart.
- •Subjects had active infections.
- •Subjects may receive other systemic antitumor therapy during the study period.
- •Other clinical trials of drugs were used in the first four weeks of the first medication.
研究组 & 干预措施
SHR 1701+radiotherapy
SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy
干预措施: SHR1701 (Drug)
结局指标
主要结局
Number of participants experiencing adverse event (AE)
时间窗: From the first administration of shr-1701 to 90 days after the last Administration
Number of participants experiencing serious adverse event (SAE)
时间窗: From the first administration of shr-1701 to 90 days after the last Administration
次要结局
- progression-free survival （PFS）(Up to approximately 24 months)
- Objective Response Rate （ORR）(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
研究者
Jinming Yu
President of Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute