Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma (MAPAC)
Osteosarcoma, Survival, Chemotherapy Effect
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring osteosarcoma, doxirubicin, cisplatin, methotrexate, ifosfamide, apatinib, camrelizumab
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
API+apatinib
MAPI+camrelizumab
MAPI
AP = Doxorubicin (Adriamycin) 20 mg/m2/day * 2 day (total/cycle 40 mg/m²) + Cisplatin 100 mg/m2/course (total/cycle 120 mg/m²); I = Ifosfamide 2000 mg/m2/day *5 day (total/cycle 10000 mg/m²); apatinib = 500 mg QD;
AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²) + Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²); M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²); camralizumab = 200mg ivgtt. Q2W;
AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²) + Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²); M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²);