Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest 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
- •An interval of 3 months or more since the fulfilling of last treatment
- •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 a history of exposure to other antiangiogenic agents
- •With other malignancies within past 3 years
- •With vital complications
- •With uncontrolled hypertension despite of medical treatment
- •With severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis
- •With brain metastasis
- •With addiction to psychiatric medications or with mental disorders
- •With severe open trauma, fracture or major surgery with past 4 weeks
- •With disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months
- •Urine protein ≥++, or 24 hr urine protein ≥1.0 g
- •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 would accept the regimen of apatinib combined with cisplatin and paclitaxel
干预措施: Chemotherapy plus apatinib (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
- Progression-free survival(One year)
- Overall survival(One year)
- Disease control rate(One year)
- Adverse event rates(One years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital