NCT05626569招募中2 期
Phase 2 Study of Anti-PD-1 Immunotherapy Combined With Stereotactic Body Radiation Therapy for Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月10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
- 40
- 试验地点
- 1
- 主要终点
- 1-year progression-free survival
研究概览
简要总结
The goal of this phase II clinical trial is to explore the efficacy and safety of anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4~6 cycles of systemic chemotherapy and anti-PD-1.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group performance status ≤ 2;
- •Histologically confirmed squamous cell carcinoma of the esophagus;
- •Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than five metastatic lesions within three organs;
- •Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease was confirmed;
- •At least one metastatic lesions amenable to the delivery of SBRT;
- •Estimated life expectancy >4 months;
- •The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min;
- •Ability to understand the study and sign informed consent.
排除标准
- •Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment;
- •Patients with intracranial metastasis disease at diagnosis;
- •History of thoracic irradiation;
- •Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;
- •Patients have spinal bone metastases combined with spinal cord compression;
- •A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
- •Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia;
- •Inability to provide informed consent due to psychological, familial, social, and other factors;
- •Female patients who are pregnant or during lactation;
- •Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
- •A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).
研究组 & 干预措施
PD-1 combined with SBRT for metastatic lesions
Experimental
Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4~6 cycles of systemic chemotherapy and anti-PD-1. SBRT for the metastatic lesions shall be conducted within two months after the completion of systemic therapy. The prescription of SBRT is determined by the investigator and the BED is required to over 50Gy.
干预措施: PD-1 combined with SBRT (Drug)
结局指标
主要结局
1-year progression-free survival
时间窗: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 12 months
1-year progression-free survival
次要结局
- 1-year overall survival(From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 12 months)
- ORR(3 months after SBRT (plus or minus 14 days)])
- Treatment-related adverse events(From the start of treatment to 2 year after the completion of treatment)
研究者
Mian XI
MD
Sun Yat-sen University
研究点 (1)
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