Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT07479732
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Osteosarcoma Metastatic

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    Intravenous liposomal irinotecan administered on Day 1, 8, and 15 of each 3-week cycle.
  • Apatinib in arm1 — DRUG
    Oral VEGFR-2 tyrosine kinase inhibitor administered in combination with liposomal irinotecan.

Study Details

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.

Key Dates

Start date
Mar 5, 2026
Status verified
Mar 2026
Primary completion
Mar 5, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib + Liposomal Irinotecan
    Patients receive apatinib orally once daily in combination with liposomal irinotecan administered intravenously every week until disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended Phase II Dose (RP2D) [ Time Frame: 6 weeks ]

Central Contacts

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