A Phase II Clinical Trial of SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinically significant toxicity
研究概览
简要总结
This is a phase II clinical trial of SHR-1210 （an anti-PD-1 Inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.
It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
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 will voluntarily participate in this study and sign informed consent.
- •NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.
- •No clear driven genes (including but not limited to EGFR, ALK).
- •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-1210 +Hypofraction radiotherapy
SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy
干预措施: SHR-1210 (Drug)
结局指标
主要结局
Clinically significant toxicity
时间窗: First cycle (28 days)
above grade 3 AEs
6-month-PFS
时间窗: From the start of treatment to 6 months.
6-month-progression free survival rate
次要结局
- DCR(at the time point of every 8 weeks)
- AEs+SAEs(from the first drug administration to within 30 days for the last SHR-1210 dose)
- PFS(up to 2 years)
- ORR(At baseline,at the time point of every 8 weeks)
- OS(up to 2 years)
研究者
Jinming Yu
Director of the hospital
Shandong Cancer Hospital and Institute