NCT03359018: APFAO

Apatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma

Completed Phase 2 Last updated 19 May 2020

What this trial tests

Phase 2 trial testing Apatinib in Progression-free Survival in 43 participants. Completed in 30 January 2020.

Timeline

1 January 2018

Primary endpoint
22 October 2019

30 January 2020

Quick facts

Lead sponsor	Peking University People's Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 January 2018
Primary completion	22 October 2019
Estimated completion	30 January 2020
Sites	2 locations across China

Drugs / interventions tested

• Apatinib (Apatinib) — full drug profile →
• SHR-1210 — full drug profile →

Conditions studied

• Progression-free Survival — all drugs for Progression-free Survival →
• Overall Survival — all drugs for Overall Survival →
• Clinical Benefit Rate — all drugs for Clinical Benefit Rate →
• Toxicity — all drugs for Toxicity →

Sponsor

Peking University People's Hospital

Who can join

11 and older, any sex, with Progression-free Survival or Overall Survival. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. We have already finished a prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a objective response rate of aproximately 45% with median progression-free survival around 5 months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in order to induce durable response in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy.

Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2 comparing with pazopanib or sorafenib.

SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Publications & conference data

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

1. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
   Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
2. Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment.
   Yi M, Jiao D, Qin S, Chu Q, et al · · 2019 · cited 487× · PMID 30925919 · DOI 10.1186/s12943-019-0974-6
3. Anti-angiogenic Agents in Combination With Immune Checkpoint Inhibitors: A Promising Strategy for Cancer Treatment.
   Song Y, Fu Y, Xie Q, Zhu B, et al · · 2020 · cited 198× · PMID 32983126 · DOI 10.3389/fimmu.2020.01956
4. Managing the immune microenvironment of osteosarcoma: the outlook for osteosarcoma treatment.
   Tian H, Cao J, Li B, Nice EC, et al · · 2023 · cited 155× · PMID 36849442 · DOI 10.1038/s41413-023-00246-z
5. Advances on immunotherapy for osteosarcoma.
   Yu S, Yao X. · · 2024 · cited 146× · PMID 39245737 · DOI 10.1186/s12943-024-02105-9
6. Advances in immune checkpoint inhibitors for bone sarcoma therapy.
   Thanindratarn P, Dean DC, Nelson SD, Hornicek FJ, et al · · 2019 · cited 126× · PMID 30775238 · DOI 10.1016/j.jbo.2019.100221
7. Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial.
   Xie L, Xu J, Sun X, Guo W, et al · · 2020 · cited 108× · PMID 32376724 · DOI 10.1136/jitc-2020-000798
8. The role of tumor-associated macrophages in osteosarcoma progression - therapeutic implications.
   Huang Q, Liang X, Ren T, Huang Y, et al · · 2021 · cited 89× · PMID 33788151 · DOI 10.1007/s13402-021-00598-w