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Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Apatinib in Combination With Ifosfamide and Etoposide (IE) for Relapsed or Refractory Osteosarcoma Progressed Upon First-line Chemotherapy (AIEO): a Prospective, Multiple-centre, Two-arm, Phase 2 Trial

NCT05277480•Peking University People's Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. advanced recurrent and refractory osteosarcoma confirmed by histopathology;
•2. initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
•3. progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
•4. measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
•5. Eastern Cooperative Oncology Group performance status ≤ 1 ;
•6. acceptable haematologic, hepatic, and renal function.

Exclusion Criteria

•1. those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
•2. those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction\<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
•3. all patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
•4. weight loss of 20% or more before illness;
•5. brain or leptomeningeal metastasis;
•6. surgical procedure or radiotherapy within 4 weeks of enrollment;
•7. activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
•8. proteinuria or hematuria, denutrition with albuminemia \<25 g/L;
•9. women who were pregnant or breast feeding, other malignancy;
•10. positive HBV/HCV/HIV serology, and known allergy to the experimental agents.

Locations (5)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2022

Primary Completion Date

June 30, 2023

Completion Date

November 26, 2023

Last Updated

July 31, 2024

Enrollment

ACTUAL participants

Conditions

Effect of DrugDrugToxicity

Interventions

Apatinib+IE

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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