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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Patients receive PLD and apatinib at the same time. The dose of intravenous chemotherapy drug is calculated according to the body surface area, and the dose of oral drug apatinib is 250mg qd. Dose suspension and dose reduction are allowed only when patients have serious adverse reactions. The intravenous chemotherapy drug PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%), and the oral drug apatinib dose is only allowed to be reduced once (250mg gravity QD changed to 250mg gravity Qod). Otherwise the patients will drop out of the study.
The dose of intravenous chemotherapy drug is calculated according to the body surface area. When patients have serious adverse reactions, dose suspension and dose reduction are allowed. The PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%).
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Guangxi Cancer Hospital
Guangxi, Guangxi, China
Hubei Cancer Hospital
Hubei, Hubei, China
Hunan Cancer Hospital
Hunan, Hunan, China
Xiangya Hospital of Central South University
Hunan, Hunan, China
The first Hospital of Jilin University
Jilin City, Jilin, China
...and 6 more locations
Progression-free Survival(PFS)
From date of randomization until the date of first documented progression or died
Time frame: up to 2 years
Overall survival(OS)
From date of randomization until the date of death from any cause
Time frame: up to 2 years
Objective response rate(ORR)
The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.
Time frame: up to 2 years
disease control rate(DCR)
including CR, PR, SD
Time frame: up to 2 years
hematological toxicity and non-hematological toxicity
including hematological toxicity and non-hematological toxicity
Time frame: up to 2 years
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