A Phase 2 interventional study of MAPI chemotherapy and Apatinib Mesylate in Osteosarcoma, Survival and Chemotherapy Effect, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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 metastases, histological response to preoperative chemotherapy and complete surgical resection. Four of the active drugs in osteosarcoma include cisplatin, doxorubicin, high-dose methotrexate and ifosfamide and this combination (MAPI), given preoperatively and postoperatively, is widely used for the treatment of osteosarcoma in China. Apatinib also has activity in advanced setting and when incorporated into the treatment of patients with metastatic disease seemed to improve progression-free survival. Combination of apatinib and camrelizumab resulted in durable therapuetic effect in selected cases. Though EURAMOUS-1 suggested that changing chemotherapy postoperatively on the basis of histological response did not improve outcomes. The exploratory study with radomised design to compare combination of chemotherapy with target drug or combination of chemotherapy with anti-PD-1 antibody versus standard chemotherapy has not been tried yet. Thus we aim to investigate the efficacy and toxicity of these combiantions versus standard chemotherapy in this study.
437 studies on the registry are indexed under Osteosarcoma; 117 are open to participants now.
This study's planned enrollment of 60 is above the median of 42 across 325 interventional studies indexed under Osteosarcoma.
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Exclusion Criteria:
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;
Drug: MAPI chemotherapy · Drug: Apatinib Mesylate
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;
Drug: MAPI chemotherapy · Drug: Camrelizumab
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);
Drug: MAPI chemotherapy
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)
anti-angiogenesis tyrosine kinase inhibitors 500 mg orally daily
anti-PD-1 antibody 200mg ivgtt. Q2W
event-free survival rate
from initial treatment after definitive surgery to progression/death/ last follow up
Time frame: 2 years
overall survival rate
from initial treatment after definitive surgery to death/ last follow up
Time frame: 5 years
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital