NCT07153952进行中（未招募）1 期
Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/Adenosquamous Carcinoma After Radiotherapy Based on Pathologic Characteristics and Multimodal Imaging: a Prospective, Multicenter Trial
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor control rate
研究概览
简要总结
This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows:
- Establish an observational prospective cohort of locally advanced ADC and randomly divide patients with residual cervical tumors in the primary site after CCRT into the local treatment group (salvage surgery or supplementary radiotherapy) or the systemic treatment group.
- Collect cervical biopsy tissues before and after CCRT in patients with residual cervical tumors, explore the genomic characteristics, and predict whether they can benefit from targeted/immunotherapy in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of cervical adenocarcinoma;
- •Age 18-80 years old;
- •FIGO 2018 stage IB3-IVA;
- •Karnofsky score≥60 points;
- •Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT;
- •No metal implants in the body, and can perform MRI examination;
- •Willing to participate in this study and provide written informed consent.
排除标准
- •Patients who have received pelvic radiotherapy before;
- •Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
- •Allergy to iodine contrast agent;
- •Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);
- •f) Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
研究组 & 干预措施
Group A: the local treatment group
Experimental
干预措施: radiotherapy (Radiation)
Group B: the systemic treatment group
Active Comparator
干预措施: Systemic treatment (Drug)
结局指标
主要结局
Tumor control rate
时间窗: Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment
次要结局
- progression-free survival(2-year progression-free survival)
- overall survival(2-year overall survival rate)
研究者
yanjunfang
Chief Assistant for Department of Radiotherapy
Peking Union Medical College Hospital
研究点 (1)
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