RecruitingPhase 1Phase 2NCT07479732

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

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

Sponsor

Peking University People's Hospital

Enrollment

56 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Osteosarcoma Metastatic

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.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — apatinib (a targeted therapy that cuts off blood supply to tumors) and liposomal irinotecan (a chemotherapy drug) — for patients with osteosarcoma (bone cancer) that has not responded to standard treatments. **You may be eligible if...** - You have been diagnosed with osteosarcoma confirmed by biopsy - Your cancer did not respond to, or came back after, at least two prior standard chemotherapy regimens - You have at least one measurable tumor that can be tracked - Your overall health is good (ECOG 0–1) and your life expectancy is at least 3 months - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have previously been treated with apatinib - You have previously been treated with irinotecan - Your side effects from prior treatments haven't resolved to a mild level - You are pregnant or breastfeeding - You have major organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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