Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Multi-Center, Open, Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This is a updated trial of NCT04188860 as a multi-center study. For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female of 18-75 years old
- •Eastern Cooperative Oncology Group score 0-1
- •Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
- •Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
- •At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
- •Anticipative survival period of 3 months or more
- •Lab testing within reference ranges
- •With appropriate contraception
- •Provided consents of participating the trial
排除标准
- •With brain metastasis
- •With addiction to psychiatric medications or with mental disorders
- •With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
- •With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
- •With infective disease which need systematic treatment within 14 days
- •With severe open trauma, fracture or major surgery with past 4 weeks
- •With potential allergy or intolerance to study regimens
- •Not eligible for the study judged by researchers
研究组 & 干预措施
Study group
The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.
干预措施: Albumin-bound paclitaxel (Drug)
Study group
The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.
干预措施: Anti-PD-1 antibody camrelizumab (Drug)
结局指标
主要结局
Overall response rate
时间窗: One year
The rates of complete and partial remission
次要结局
- Overall survival(One year)
- Adverse event rates(One year)
- Progression-free survival(One year)
- Disease control rate(One year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital