NCT04351308: MAPAC

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

Status unknown Phase 2 Last updated 19 May 2020

What this trial tests

Phase 2 trial testing MAPI chemotherapy in Osteosarcoma in 60 participants. Status unknown.

Timeline

1 May 2020

Primary endpoint
1 September 2022

31 December 2022

Quick facts

Lead sponsor	Peking University People's Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 May 2020
Primary completion	1 September 2022
Estimated completion	31 December 2022
Sites	1 location across China

Drugs / interventions tested

• MAPI chemotherapy — full drug profile →
• Apatinib Mesylate
• Camrelizumab — full drug profile →

Conditions studied

• Osteosarcoma — all drugs for Osteosarcoma →
• Survival — all drugs for Survival →
• Chemotherapy Effect — all drugs for Chemotherapy Effect →
• Toxicity, Drug — all drugs for Toxicity, Drug →

Sponsor

Peking University People's Hospital

Who can join

12 and older, any sex, with Osteosarcoma or Survival. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances on immunotherapy for osteosarcoma.
   Yu S, Yao X. · · 2024 · cited 146× · PMID 39245737 · DOI 10.1186/s12943-024-02105-9
2. Pathogenesis and Current Treatment of Osteosarcoma: Perspectives for Future Therapies.
   Rathore R, Van Tine BA. · · 2021 · cited 81× · PMID 33809018 · DOI 10.3390/jcm10061182
3. Targeting the VEGF Pathway in Osteosarcoma.
   Assi T, Watson S, Samra B, Rassy E, et al · · 2021 · cited 50× · PMID 34069999 · DOI 10.3390/cells10051240
4. Immune checkpoint inhibitors in osteosarcoma: A hopeful and challenging future.
   Zhang Z, Tan X, Jiang Z, Wang H, et al · · 2022 · cited 37× · PMID 36324681 · DOI 10.3389/fphar.2022.1031527
5. Promise and Challenges of T Cell Immunotherapy for Osteosarcoma.
   Park JA, Cheung NV. · · 2023 · cited 26× · PMID 37569894 · DOI 10.3390/ijms241512520
6. Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.
   Just MA, Van Mater D, Wagner LM. · · 2021 · cited 23× · PMID 33894051 · DOI 10.1002/pbc.29084
7. Tyrosine kinase inhibitors in sarcoma treatment.
   Kyriazoglou A, Gkaralea LE, Kotsantis I, Anastasiou M, et al · · 2022 · cited 19× · PMID 35527786 · DOI 10.3892/ol.2022.13303
8. Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial.
   Palmerini E, Lopez Pousa A, Grignani G, Redondo A, et al · · 2025 · cited 14× · PMID 39540661 · DOI 10.1002/cncr.35628