Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT04351308
Phase
PHASE2
Status
Unknown

Conditions

  • Chemotherapy Effect
  • Osteosarcoma
  • Survival
  • Toxicity, Drug

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MAPI chemotherapy — DRUG
    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)
  • Apatinib Mesylate — DRUG
    anti-angiogenesis tyrosine kinase inhibitors 500 mg orally daily
  • Camrelizumab — DRUG
    anti-PD-1 antibody 200mg ivgtt. Q2W

Study Details

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.

Key Dates

Start date
May 1, 2020
Status verified
May 2020
Primary completion
Sep 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: API+apatinib
    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;
  • Experimental: MAPI+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); camralizumab = 200mg ivgtt. Q2W;
  • Active Comparator: MAPI
    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);

Primary Outcome Measure

event-free survival rate [ Time Frame: 2 years ]

Central Contacts

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