Status:
COMPLETED
Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Effect of Drug
Drug
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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 musc...
Eligibility Criteria
Inclusion
- advanced recurrent and refractory osteosarcoma confirmed by histopathology;
- initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
- progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
- measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
- Eastern Cooperative Oncology Group performance status ≤ 1 ;
- acceptable haematologic, hepatic, and renal function.
Exclusion
- those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
- 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.;
- 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;
- weight loss of 20% or more before illness;
- brain or leptomeningeal metastasis;
- surgical procedure or radiotherapy within 4 weeks of enrollment;
- activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
- proteinuria or hematuria, denutrition with albuminemia \<25 g/L;
- women who were pregnant or breast feeding, other malignancy;
- positive HBV/HCV/HIV serology, and known allergy to the experimental agents.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05277480
Start Date
March 1 2022
End Date
November 26 2023
Last Update
July 31 2024
Active Locations (5)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Peking University People's Hospital
Beijing, Beijing Municipality, China
3
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
4
Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China