Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Local control
研究概览
简要总结
Immunotherapy is now considered to be one of promising approaches for treating cancer. Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal cancer. Radiation-induced mutation genes were identified as new sources of tumor associated antigens using exon sequencing and peptide microarray technologies. Epitope peptides for these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL therapy in combination with radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.
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
- 否
入选标准
- •Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus.
- •measurable disease by CT scan
- •ECOG performance status of 0 to 2
- •Expected survival of at least 3months
- •Laboratory values as follow:
- •Absolute neutrophil count (ANC) ≥ 1.5×109
- •White blood cell count ≥ 3×109/L
- •Platelets ≥ 100×109/L
- •Haemoglobin (Hb) ≥ 10g/dL (patients'Hb should be corrected to >10g/dL before treatment)
- •Adequate liver function (within 1 week prior to randomization)
- •Serum bilirubin ≤ 1.5× ULN
- •Alanine aminotransferase/aspartate transaminase (ALT / AST) ≤ 2.5× ULN
- •Alkaline phosphatase (ALP) ≤ 3× ULN
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Active or uncontrolled infection
- •Prior chemotherapy, radiation therapy or immunotherapy
- •Concurrent treatment with steroid or immunosuppressing agent
- •Patient with peptic ulcer disease
- •Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
- •Disease to the central nervous system
- •Decision of unsuitableness by principal investigator or physician-in-charge
研究组 & 干预措施
peptide specific CTL arm
peptide specific CTL, radiation
干预措施: peptide specific CTL (Biological)
结局指标
主要结局
Local control
时间窗: two years after enrollment
occurrence of local or regional progression
次要结局
- Overall survival(1 year)
- Objective response rate as assessed by RECIST criteria(3 months)
- Time to progression(1 year)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](3 months)
研究者
Shixiu Wu
director of the hospital
Hangzhou Cancer Hospital