Status:
UNKNOWN
Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Chinese Sarcoma Study Group
Conditions:
Osteosarcoma
Survival
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%. The most common factors predicting survival are presence of m...
Eligibility Criteria
Inclusion
- Histologically confirmed high-grade osteosarcoma, including second malignancies
- Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
- Suitable for neoadjuvant chemotherapy and adjuvant chemotherapy
- Performance status - Lansky 50-100% (for patients under 16 years of age); Performance status - WHO or ECOG 0-2 with a life expectancy \>3 months
- normal cardiac function (shortening fraction \>28%), normal hearing, normal bone marrow as shown by an absolute neutrophil count of at least 1·5 × 10⁹ cells per L (or a white blood cell count of at least 3 × 10⁹ cells per L if neutrophil count is not available), and a platelet count of at least 100 000 platelets per μL
- Patients were also required to have a serum bilirubin concentration of at most less than 1·5 times the upper limit of normal and a normal creatinine concentration for their age as per protocol
- Women of child-bearing potential had to take adequate contraceptive measures and have a negative pregnancy test within 7 days of study entry.
Exclusion
- patients who have recieved anti-angiogenic TKIs or anti-PD-1/PD-L1 antibodies
- allergy to chemotherapy or apatinib or camrelizumab
- other severe illness (eg, psychosis or previous history of cardiovascular disease)
- symptomatic or known CNS metastases
- previous or concurrent second primary malignant tumours
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on
- had other infections or wounds
- pregnant or breastfeeding.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04351308
Start Date
May 1 2020
End Date
December 31 2022
Last Update
May 19 2020
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044