A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The change of expression of PD-L1+ on cervix biopsies
研究概览
简要总结
Perspectives:
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.
To evaluate the specific immune response throughout monitor the change of the programmed death-1(PD-1) in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To use immunohistochemistry (IHC) technique to monitor the change of programmed death-ligand 1 (PD-L1),CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To detect the change of T cell receptor(TCR) repertoire and Tumor mutation burden (TMB) at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
详细描述
Cervical cancer is the fourth most common cancer among women worldwide. At present, patients with cervical cancer are treated with radical hysterectomy and pelvic lymphadenectomy or chemoradiation. To improve the prognosis of cervical cancer patients, novel immunotherapeutic strategies need to be developed. Now there are some clinical phase I/II trials ongoing to assess the effects of ipilimumab, pembrolizumab and nivolumab in advanced cervical cancer,but information on the clinical significance of PD-L1 expression in cervical cancer is largely lacking.In this study, the investigator's primary objective:
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.
To evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To use IHC technique to monitor the change of PD-L1, CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
To detect the change of TCR repertoire and TMB at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.
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
- •Age:18-70 years.
- •All FIGO stages cervical cancers which are the matter for radiochemotherapy and exclusive brachytherapy indications.
- •Ability to give informed consent.
- •Patients must be affiliated to a Social Security System.
- •Patient information and written informed consent form signed.
排除标准
- •Known autoimmune disorder.
- •History of HIV and/ or active hepatitis infection.
- •History of pelvic radiation or radio-chemotherapy.
- •Recurrent or metastatic cervical cancer.
- •Contra-indication for cisplatin.
- •Patient pregnant and/or breastfeeding.
- •Patients with psychological or familial disease potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
Cisplatin
Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.
干预措施: Cisplatin (Drug)
结局指标
主要结局
The change of expression of PD-L1+ on cervix biopsies
时间窗: From baseline,3 weeks,2 months
The biopsy was collected at baseline,3 weeks,2 months
次要结局
- The change of expression of CD8+PD1+ lymphocytes infiltrate on cervix biopsies(baseline,3 weeks,2 months)
- The diversity of T-cell Repertoire in cervix biopsies and blood, respectively(baseline,3 weeks,2 months)
- The change of expression of PD1 on the non-regulatory CD4+ and CD8+ lymphocytes and Treg cells(baseline,3 weeks,2 months)
研究者
You Lu
Chair of Department of Thoracic Oncology
Sichuan University