NCT04348032: APPROVE

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

Status unknown Phase 2 Last updated 31 March 2022

What this trial tests

Phase 2 trial testing PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd in Platinum-resistant Recurrent Ovarian Cancer in 152 participants. Status unknown.

Timeline

22 March 2018

Primary endpoint
28 January 2021

30 June 2022

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	22 March 2018
Primary completion	28 January 2021
Estimated completion	30 June 2022
Sites	16 locations across China

Drugs / interventions tested

• PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd — full drug profile →
• PLD 40mg/m2 ivgtt q4w — full drug profile →

Conditions studied

• Platinum-resistant Recurrent Ovarian Cancer — all drugs for Platinum-resistant Recurrent Ovarian Cancer →

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

18 and older, female only, with Platinum-resistant Recurrent Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
2. Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
   Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
3. Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial.
   Wang T, Tang J, Yang H, Yin R, et al · · 2022 · cited 57× · PMID 35771546 · DOI 10.1001/jamaoncol.2022.2253
4. Overcoming the challenges of drug development in platinum-resistant ovarian cancer.
   Eskander RN, Moore KN, Monk BJ, Herzog TJ, et al · · 2023 · cited 24× · PMID 37916177 · DOI 10.3389/fonc.2023.1258228
5. Role of tumor microenvironment in ovarian cancer metastasis and clinical advancements.
   Wang Y, Zhu N, Liu J, Chen F, et al · · 2025 · cited 15× · PMID 40369674 · DOI 10.1186/s12967-025-06508-0
6. Targeted therapy and immunotherapy: Diamonds in the rough in the treatment of epithelial ovarian cancer.
   Huang X, Li XY, Shan WL, Chen Y, et al · · 2023 · cited 14× · PMID 37033645 · DOI 10.3389/fphar.2023.1131342
7. How to win the ovarian cancer stem cell battle: destroying the roots.
   Takahashi A, Hong L, Chefetz I. · · 2020 · cited 13× · PMID 35582216 · DOI 10.20517/cdr.2020.93
8. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.
   Newhouse R, Nelissen E, El-Shakankery KH, Rogozińska E, et al · · 2023 · cited 11× · PMID 37407274 · DOI 10.1002/14651858.cd006910.pub3