Status:
SUSPENDED
Apatinib Plus IE Chemotherapy (Ifosfamide and Etoposide) for Relapsed or Refractory Osteosarcoma
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking University Shougang Hospital
Conditions:
Effect of Drug
Toxicity, Drug
Eligibility:
All Genders
12-70 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
- 1\) histologically confirmed high-grade osteosarcoma;
- 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 ≤ 2 ;
- 6\) 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 :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04824352
Start Date
April 1 2021
End Date
April 1 2026
Last Update
May 14 2024
Active Locations (2)
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1
Peking University Shougang Hospital
Beijing, Beijing Municipality, China, 100035
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044