Apatinib Combined With PLD vs PLD for Platinum-resistant Recurrent Ovarian Cancer

Phase 2

• Conditions: Platinum-resistant Recurrent Ovarian Cancer
• Interventions: Drug: PLD 40mg/m2 ivgtt q4w; Drug: PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd

• Registration Number: NCT04348032
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-03-22
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Primary Completion: 2021-01-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival(PFS)	up to 2 years	From date of randomization until the date of first documented progression or died

Secondary Outcome Measures

Name	Time	Method
disease control rate(DCR)	up to 2 years	including CR, PR, SD
Overall survival(OS)	up to 2 years	From date of randomization until the date of death from any cause
hematological toxicity and non-hematological toxicity	up to 2 years	including hematological toxicity and non-hematological toxicity
Objective response rate(ORR)	up to 2 years	The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.

Trial Locations

Locations (16)

National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Hubei Cancer Hospital; 🇨🇳 Hubei, Hubei, China

Shandong Cancer Hospital; 🇨🇳 Shangdong, Shangdong, China

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Guangxi Cancer Hospital; 🇨🇳 Guangxi, Guangxi, China

Hunan Cancer Hospital; 🇨🇳 Hunan, Hunan, China

Xiangya Hospital of Central South University; 🇨🇳 Hunan, Hunan, China

The first Hospital of Jilin University; 🇨🇳 Jilin, Jilin, China

Liaoning Cancer Hospital; 🇨🇳 Liaoyang, Liaoning, China

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tumor Hospital of Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China

Yunnan Cancer Hospital; 🇨🇳 Yunnan, Yunnan, China

Tumor Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China