A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- AEs and SAEs at 6 months
研究概览
简要总结
This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.
SECONDARY OBJECTIVES:
I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.
II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.
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
- •Signed inform consent form
- •Age >= 18 years and <= 75 years
- •Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
- •Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Life expectancy >= 8 weeks
- •Adequate hematologic and end organ function
排除标准
- •Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
- •Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
- •Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
- •No active second cancers
- •Active or prior autoimmune disease or immunodeficiency.
- •Active infections including but not limited to hepatitis B, C ,and HIV.
- •Significant cardiovascular disease
- •Active or untreated central nervous system (CNS) metastases
- •Any unresolved toxicity CTCAE >= Grade 3 from the prior radiation therapy.
- •Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.
- •Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.
研究组 & 干预措施
Anti-PD-1 antibody
IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.
干预措施: IBI308 (Drug)
结局指标
主要结局
AEs and SAEs at 6 months
时间窗: 6 months
Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]
次要结局
- ORR(Estimated to be up to 3 years)
- DoR(Estimated to be up to 3 years)
- AEs(Estimated to be up to 3 years)
- PFS(Estimated to be up to 3 years)
- OS(Estimated to be up to 3 years)
研究者
Haihua Yang
Head of Department of Radiation Oncology, Chief Physician
Taizhou Hospital