Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT03358628
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years;
2. Diagnosis confirmed histologically and reviewed centrally;
3. Prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
4. Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
5. Adequate renal, hepatic, and hemopoietic function;
6. Normal or controlled blood pressure;
7. Surgery and/or radiotherapy completion at least 1 month before enrollment.
Exclusion Criteria:
1. Central nervous system metastasis;
2. Have had other kinds of malignant tumors at the same time;
3. Cardiac insufficiency or arrhythmia;
4. Uncontrolled complications, such as diabetes mellitus and so on;
5. Coagulation disorders;
6. Urine proteinā„ ++;
7. Pleural or peritoneal effusion that needs to be handled by surgical treatment;
8. Combined with other infections or wounds.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03358628
Study Brief:
Protocol Section:
NCT03358628