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RECRUITING
NCT07479732
PHASE1/PHASE2

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

In advanced osteosarcoma where traditional chemotherapy has failed, the multi-targeted tyrosine kinase inhibitor apatinib has become a mainstream systemic treatment option in China. However, for patients with a high tumor burden or extra-pulmonary lesions, these drugs are prone to secondary resistance, necessitating combination with chemotherapy for more effective comprehensive control. Liposomal irinotecan, a newly approved topoisomerase inhibitor, exhibits lower toxicity compared to traditional irinotecan and is one of the second-line chemotherapy agents for osteosarcoma, making it a suitable candidate for combination therapy with apatinib. The primary objective of this study is to determine the optimal regimen of apatinib combined with liposomal irinotecan injection, while the secondary objective is to evaluate the safety and efficacy of this combination in patients with refractory osteosarcoma who have progressed after second-line chemotherapy.

Official title: Safety and Efficacy of Apatinib Combined With Irinotecan Liposome Injection in the Treatment of Recurrent or Metastatic Osteosarcoma: A Single-Arm, Open-Label, Prospective Multicenter Clinical Study

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-03-05

Completion Date

2028-01-01

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Liposomal Irinotecan

Intravenous liposomal irinotecan administered on Day 1, 8, and 15 of each 3-week cycle.

DRUG

Apatinib in arm1

Oral VEGFR-2 tyrosine kinase inhibitor administered in combination with liposomal irinotecan.

Locations (1)

Peking University People's Hospital

Beijing, China