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

Conditions

• Platinum-resistant Recurrent Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd — DRUG
  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.
• PLD 40mg/m2 ivgtt q4w — DRUG
  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%).

Study Details

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.

Key Dates

Start date

Mar 22, 2018

Status verified

Mar 2022

Primary completion

Jan 28, 2021

Completion

Jun 30, 2022

Study Design

Enrollment

152 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PLD
  PLD 40 mg/m2 D1 ivgtt q4w
• Experimental: PLD + Apatinib
  PLD 40 mg/m2 D1 ivgtt q4w + Apatinib 250mg po qd

Primary Outcome Measure

Progression-free Survival(PFS) [ Time Frame: up to 2 years ]