NCT05277480 (OAIE) is a Phase 2 clinical trial of Apatinib+IE in Effect of Drug, sponsored by Peking University People's Hospital.

Who is sponsoring NCT05277480?

NCT05277480 is sponsored by Peking University People's Hospital.

What drugs are being tested in NCT05277480?

Interventions in NCT05277480: Apatinib+IE, IE.

What condition does NCT05277480 study?

NCT05277480 studies Effect of Drug, Drug, Toxicity.

Is NCT05277480 still recruiting?

NCT05277480 is currently completed. Last updated 31 July 2024.

Last reviewed 2024-07-31 · How we verify

NCT05277480: OAIE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)

Completed Phase 2 Last updated 31 July 2024

What this trial tests

Phase 2 trial testing Apatinib+IE in Effect of Drug in 81 participants. Completed in 26 November 2023.

Timeline

1 March 2022

Primary endpoint
30 June 2023

26 November 2023

Quick facts

Lead sponsor	Peking University People's Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	81
Start date	1 March 2022
Primary completion	30 June 2023
Estimated completion	26 November 2023
Sites	5 locations across China

Drugs / interventions tested

Apatinib+IE — full drug profile →
IE — full drug profile →

Conditions studied

Effect of Drug — all drugs for Effect of Drug →
Drug — all drugs for Drug →
Toxicity — all drugs for Toxicity →

Sponsor

Peking University People's Hospital

Who can join

Adults 12 to 65, any sex, with Effect of Drug or Drug. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.

Publications & conference data

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

Apatinib plus ifosfamide and etoposide versus ifosfamide and etoposide in patients with advanced osteosarcomas (OAIE/PKUPH-sarcoma 11): a randomized phase II study.
Xie L, Xu J, Sun X, Liu K, et al · · 2025 · cited 1× · PMID 41290609 · DOI 10.1038/s41467-025-65467-8
Role of tumor-derived exosomes and immune cells in osteosarcoma progression and targeted therapy.
Wang J, Shi K. · · 2025 · PMID 41383602 · DOI 10.3389/fimmu.2025.1658358
Randomized Study of Apatinib plus Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Patients With Advanced Osteosarcomas (OAIE/PKUPH-sarcoma 11)
Tang X, Xie L, Xu J, Sun X, et al · · 2025 · DOI 10.21203/rs.3.rs-5641573/v1

Verify or expand the search:

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Other Peking University People's Hospital trials

Trials by the same sponsor.

NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia · Phase 1, PHASE2 · not yet recruiting
NCT07516002 — Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency · not yet recruiting
NCT07294339 — A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positiv · NA · not yet recruiting
NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05277480 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
Last refreshed: 31 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05277480.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing