跳至主要内容
临床试验/NCT04348032
NCT04348032Unknown2 期

Apatinib Combined With PLD vs PLD for Platinum-resistant Recurrent Ovarian Cancer(APPROVE): a Randomized, Controlled, Open-label, Phase 2 Trial

Chinese Academy of Medical Sciences16 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2018年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
152
试验地点
16
主要终点
Progression-free Survival(PFS)

研究概览

简要总结

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The prognosis of patients with platinum-resistant or refractory ovarian cancer was very poor, with the response rate of 20%~25% after chemotherapy. The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. Angiogenesis is essential for tumor growth and metastasis.And VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target due to its key roles in angiogenesis and tumor growth.This study sought to assess the efficacy and safety of the combination therapy of apatinib and PLD, clarifying whether combination therapy could improve the outcomes of patients with platinum-resistant recurrent ovarian cancer.

详细描述

This study is a randomized, parallel-controlled, multicenter clinical study. We recruit patients over the age of 18 years with platinum-resistant recurrent ovarian cancer. patients who meet the criteria for enrollment are randomly divided into two groups, including experiment group and control group. This study will be divided into three stages: 1. Baseline period (within 21 days before the start of treatment): Patients will complete screening tests during the baseline period to assess whether they meet the selection criteria. 2. Treatment period (from the first administration to the completion of the last treatment cycle). The tumor will be evaluated every 8 weeks during this period. If the treatment is effective, the chemotherapy does not exceed 6 cycles,then experiment group receives oral apatinib maintenance therapy until the disease progresses or toxicity could not be tolerated. Control group is followed up. 3. Follow-up period. After the end of chemotherapy, the survival status and follow-up anti-tumor therapy are collected by telephone or research centers visit every 3 months until death or loss of follow-up.The primary endpoint is the progression-free survival time(PFS) of patients and is judged according to Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events are classified and recorded according to the National Cancer Institute's Standard of Common terms for adverse reactions (NCI-CTCAE) version 4.0.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

PLD

Active Comparator

PLD 40 mg/m2 D1 ivgtt q4w

干预措施: PLD 40mg/m2 ivgtt q4w (Drug)

PLD + Apatinib

Experimental

PLD 40 mg/m2 D1 ivgtt q4w + Apatinib 250mg po qd

干预措施: PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd (Drug)

结局指标

主要结局

Progression-free Survival(PFS)

时间窗: up to 2 years

From date of randomization until the date of first documented progression or died

次要结局

  • disease control rate(DCR)(up to 2 years)
  • Overall survival(OS)(up to 2 years)
  • hematological toxicity and non-hematological toxicity(up to 2 years)
  • Objective response rate(ORR)(up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling-Ying Wu

chief physician

Chinese Academy of Medical Sciences

研究点 (16)

Loading locations...

相似试验