Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorPeking University People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
The subject or their legal representative must sign a written informed consent form prior to enrollment.
Diagnosis of refractory osteosarcoma confirmed by histopathology. Pathological confirmation is mandatory for localized tumors and isolated pulmonary lesions; it is not required for multiple pulmonary metastases.
Disease progression after standard, adequate first-line and second-line chemotherapy regimens for osteosarcoma, or progression within 6 months of stopping such therapy.
At least one measurable target lesion according to RECIST version 1.1 criteria.
Disqualifiers
Prior treatment with apatinib.
Prior use of irinotecan or other analogues of topoisomerase inhibitors.
Known allergic reactions, hypersensitivity, or intolerance to apatinib, liposomal irinotecan, or any of their excipients.
Within 3 weeks after the last dose of any prior therapy, including systemic cytotoxic drug therapy, targeted therapy, radiotherapy, immunotherapy, or any other investigational therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Liposomal Irinotecan
DrugIntravenous liposomal irinotecan administered on Day 1, 8, and 15 of each 3-week cycle.
Apatinib in arm1
DrugOral VEGFR-2 tyrosine kinase inhibitor administered in combination with liposomal irinotecan.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Apatinib + Liposomal IrinotecanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recommended Phase II Dose (RP2D)
Determination of the recommended phase II dose based on dose-limiting toxicity (DLT) observed during the first two cycles (6 weeks).
Time frame
6 weeksSecondary outcomes
1
Objective Response Rate (ORR)
Time frame
Every 6 weeks up to 24 months2
Progression-Free Survival (PFS)
Time frame
From treatment initiation until disease progression or death, up to 24 months3
Overall Survival，OS
Time frame
From treatment initiation until death from any cause, up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov