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

Last updated: May 15, 2020
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Osteosarcoma

Treatment

N/A

Clinical Study ID

NCT04351308
PKUPH-sarcoma 09
  • Ages > 12
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed high-grade osteosarcoma, including second malignancies

  • Tumor (primary, metastatic, or both) resectable OR is expected to become resectableafter neoadjuvant induction chemotherapy

  • Suitable for neoadjuvant chemotherapy and adjuvant chemotherapy

  • Performance status - Lansky 50-100% (for patients under 16 years of age); Performancestatus - WHO or ECOG 0-2 with a life expectancy >3 months

  • normal cardiac function (shortening fraction >28%), normal hearing, normal bone marrowas shown by an absolute neutrophil count of at least 1·5 × 10⁹ cells per L (or a whiteblood cell count of at least 3 × 10⁹ cells per L if neutrophil count is notavailable), 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 lessthan 1·5 times the upper limit of normal and a normal creatinine concentration fortheir age as per protocol

  • Women of child-bearing potential had to take adequate contraceptive measures and havea negative pregnancy test within 7 days of study entry.

Exclusion

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, urineprotein ≥ ++, and so on

  • had other infections or wounds

  • pregnant or breastfeeding.

Study Design

Total Participants: 60
Study Start date:
May 01, 2020
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Peking University People's Hospital

    Beijing, 100044
    China

    Active - Recruiting

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