Neoadjuvant Chemotherapy Combined With PD-1 Antibody + Radical Radiotherapy in Unresectable Locally Advanced Cervical Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.
详细描述
3.1 Overall study design and planning This study is a prospective, single-arm, phase II, single-center study. Eligible patients with locally advanced cervical cancer entered the trial arm, and all patients received three cycles of 21 days each, with chemotherapy on day 1 (nab-paclitaxel 150 mg/m2 plus cisplatin 75 mg/m2) and camrelizumab 200 mg, followed by radical radiotherapy. Treatment-related acute events were recorded during treatment. Survival period was followed up after the end of treatment, so far the trial treatment ended. (See the following test flow diagram for details).
Schematic diagram of the test process:
3.2 Study population 3.2.1 Selection criteria
- Age 18-70 years old;
- Histologically diagnosed as cervical squamous cell carcinoma; clinical evaluation cannot be surgically removed;
- According to the 2018 International Federation of Obstetrics and Gynecology (FIGO) cervical cancer staging for locally advanced patients, including inoperable stage IIB, IIIA, IIIB, IIIC, IVa;
- No previous treatment for cervical cancer;
- According to RECIST version 1.1 criteria, there is at least one evaluable target lesion;
- ECOG fitness status is 0-1 points;
- The function of major organs is normal, that is, the following criteria are met:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who were pathologically diagnosed with cervical squamous cell carcinoma and were assessed as unresectable.
排除标准
- •Any active or present autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)
结局指标
主要结局
Objective Response Rate
时间窗: 4 weeks after all treatments
refers to the proportion of patients whose tumors shrink to a certain amount and maintain for a certain period of time (4 weeks after all treatments), including CR+PR cases. CR (complete remission): disappearance of all target lesions, PR (partial remission): reduction of the sum of the length and diameter of the baseline lesions by ≥30%
次要结局
- DFS(year 1 and year 5)
- OS(year 1 and year 5)
- Side effects(during the procedure)
研究者
Xiaojing Yang
Principal Investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital