Actively Recruiting
Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma
Led by Peking University People's Hospital · Updated on 2026-03-18
56
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before joining the study
- Confirmed diagnosis of refractory osteosarcoma by pathology
- Disease progression after standard first-line and second-line chemotherapy, or progression within 6 months after stopping such treatment
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1 and expected survival of at least 3 months
- Recovery from previous treatments with side effects resolved to Grade 1 or lower (except hair loss)
- Adequate organ function based on blood counts and serum tests
- Women of childbearing potential must use effective contraception during the study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
- Male participants must use effective contraception or be surgically sterile during the study and for 6 months after completion
You will not qualify if you...
- Prior treatment with apatinib
- Prior use of irinotecan or similar topoisomerase inhibitors
- Known allergies or intolerance to apatinib, liposomal irinotecan, or their components
- Received any prior therapy within 3 weeks before starting the study
- Diagnosis of other cancers within the past 3 years except certain treated skin or cervical cancers and breast cancer disease-free for over 3 years
- Brain metastases, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, or unstable brain lesions
- Symptomatic fluid build-up in chest, abdomen, or around the heart needing surgery
- Uncontrolled high blood pressure despite treatment
- Other poorly controlled medical conditions
- Participation in other cancer drug trials within 4 weeks prior to enrollment
- Use of strong CYP3A4 inhibitors within 7 days or inducers within 12 days before joining
- Currently receiving other anticancer treatments
- Target lesions previously treated with radiotherapy without progression
- Received vaccination during study or adenovirus-based vaccine within 4 weeks
- Breastfeeding women
- Any condition deemed by investigators to affect safety or study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xie Lu LuXie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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