Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway
试验速览
- 阶段
- 3 期
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- PFS（Progression-Free-Survival)
研究概览
简要总结
Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.
详细描述
Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-75 years old
- •PS score: ECOG 0 ~ 2
- •histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;
- •the time interval between this recurrence and the last chemotherapy was 6-12 months;
- •evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;
- •expected survival over 3 months;
- •sign the informed consent.
排除标准
- •brain metastasis or the presence of symptoms caused by brain metastasis;
- •serious complications;
- •acute inflammatory reaction;
- •other tumors;
- •a history of allergy to paclitaxel or polyropyridone liposomes;
研究组 & 干预措施
PP
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.
干预措施: Doxorubicin Hydrochloride Liposome Injection+carboplatin (Drug)
TP
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
干预措施: paclitaxel +carboplatin (Drug)
结局指标
主要结局
PFS（Progression-Free-Survival)
时间窗: up to 24months
From the date of randomization to the time of tumor progression
次要结局
- OS(Overall survival)(up to 36months)
- ORR( Objective response rate)(up to 12 months)
研究者
JingWang
Professor
Hunan Cancer Hospital