advanced tumor
Conditions
Interventions
1:Genexol-PM
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients were considered eligible if they had histological evidence of advanced solid malignancies refractory to conventional treatment or for whom no effective therapy existed; 2. Age 18-75, both genders; 3. Eastern Cooperative Oncology Group performance status less than 2; 4. Life expectancy more than 3 months; 5. no prior chemotherapy, immunotherapy, or radiation therapy for a period of 4 weeks; 6. Blood routine examination should meet the following criteria: (1) Hb more than 90g/L; (2) ANC more than 1.5*10^9/L; (3) PLT more than 80*10^9/L; 7. Blood biochemistry examination should meet the following criteria: (1) ALT, AST less than 1.5*ULN (Patients with liver metastases: ALT, AST less than 5*ULN, patients with bone metastases: ALT, AST less than 10*ULN); (2) TBIL less than 1.5*ULN; (3) Cr less than 1.5*ULN; 8. Measurable lesions in line with the requirement of "RECIST", or part of unmeasurable lesions; 9. Understanding the purpose of clinical trials, willing to participation and sign ICF; 10. Willingness and capability to be accessible for study follow-up.
Exclusion criteria
Exclusion criteria: 1. The primary brain tumor had not been controlled; 2. With a grade II or above in peripheral neuropathy (NCI CTC AE V3.0); 3. Patients with mental illness or mental disorders; 4. activity in severe infection (more than NCI-CTC 3 2); 5. patients with bronchial asthma; 6. Patient with diabetic had not controlled; 7. Patients with severe epilepsy needs drug treatment; 8. Patients who had important organ disorders or diseases, such as liver and kidney dysfunction, myocardial infarction, unstable heart disease, chronic active hepatitis etc; 9. Other malignant tumors in five years (in addition to the cured skin basal cell carcinoma); 10. Patients who had taken other therapy within 4 weeks of enrollment; 11. Women during pregnancy or lactation; 12. There was a clear history of allergies to genexol products; 13. Drug abuse affecting the study evaluates; 14. Any unstable or dangerous situations that may affecting safety and compliance of patients in this study; 15. Patients are determined other unsuitable symptoms or events to participate in the study, such as transplants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability; | — |
Contacts
Public ContactFENG JI FENG
Outcome results
None listed