A Phase II Clinical Trial of Consolidation Therapy Guided by MRD Testing After Radical Radiotherapy for Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Median progression-free survival (PFS)
研究概览
简要总结
To further validate the performance of the high-sensitivity MRD assay in patients with squamous esophageal cancer who have completed radical radiotherapy; to validate whether MRD-negative patients can maintain a good prognosis under regular follow-up; and to validate whether MRD-positive patients can improve their survival with consolidation therapy with PD-1 monotherapy.
详细描述
Esophageal cancer is one of the most common lethal tumours in the world and accounts for more than 50% of new cases in China. Definitive concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal cancer, and the 5-year survival rate is only about 30%, but due to the lack of evidence, consolidation therapy has not been explicitly recommended in major guidelines.
In the CheckMate 577 study, patients who did not achieve pathological complete response (pCR) after surgery improved their survival through immunology consolidation therapy with PD-1 monotherapy, suggesting that patients who did not achieve clinical complete response (cCR) after radiotherapy may benefit from immunology consolidation therapy. This suggests that patients who do not have a clinical complete response (cCR) after radiotherapy are likely to benefit from immunology consolidation therapy. Patients with cCR after radiotherapy may achieve similar results to those achieved with radical surgery, and consolidation is probably not necessary.
However, existing clinical practice is unable to accurately determine the efficacy of radiotherapy in esophageal cancer, making risk-of-recurrence-guided stratified consolidation strategies difficult to achieve. Most of the ongoing radiotherapy-immunotherapy studies in esophageal cancer have been designed to treat all patients indiscriminately with immunology consolidation therapy, which may lead to over-treatment of cCR patients.
Therefore, there is an urgent need to find easily accessible and reliable biomarkers for the efficacy of radiotherapy in esophageal cancer, and to carry out prospective clinical studies as soon as possible, so as to optimize the strategy of consolidation therapy after radiotherapy in esophageal cancer. The high sensitivity of minimal residual disease (MRD) detection technology established by the researcher's team provides a prerequisite for this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years, any gender
- •Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is I-VIa (2018 AJCC Cancer Staging Manual, 8th Edition) , primary unresectable oesophageal cancer
- •ECOG performance status <=
- •No significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function
- •Completed radical radiotherapy (dose 50-60Gy);
- •Received a systemic regimen of platinum in combination with paclitaxel or a 5-FU-based two-drug regimen with or without PD-1 monotherapy in accordance with the CSCO guidelines, and S-1 monotherapy in elderly patients;
- •Informed consent
排除标准
- •Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- •Active infection currently exists, serious illness such as myocardial infarction in the 6 months prior to enrolment
- •History of autoimmune diseases
- •Participate in other clinical trials at present or within 4 weeks before enrollment;
- •Received systemic therapy (chemotherapy alone or chemotherapy combined with immunotherapy) for more than 4 cycles.
研究组 & 干预措施
MRD positive
Intervention name: PD-1 monoclonal antibody consolidation therapy;
干预措施: PD-1 monoclonal antibody consolidation therapy (Drug)
结局指标
主要结局
Median progression-free survival (PFS)
时间窗: 36 month
Median progression-free survival (PFS), was defined as the time from the end of radiotherapy to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.
次要结局
- 5-year overall survival(60 month)
- Cancer specific survival(60 month)
- General Quality of life score(QOL)(36 month)
- Incidence of radiotherapy and immunotherapy related toxicity(Through study completion, an average of 3 year)
- Quality of life score(QOL) for swallowing function(36 month)