Advanced malignant tumors including, but not limited to, pancreatic cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, breast cancer, sarcoma etc.
Conditions
Interventions
1:Local and Intratumoral Administration
2:intravenous therapy
Sponsors
Xuzhou Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of advanced, recurrent or metastatic malignant tumors including, but not limited to, pancreatic cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, breast cancer,sarcoma etc.; 2. At least 4 weeks since prior cytotoxic chemotherapy, interventional therapy or targeted therapy and must have recovered from them completely; 3. ECOG performance status 0-2; 4. Life expectancy >=3 months; 5. Laboratory values must fulfill all of the following criteria: absolute neutrophil count(ANC)>=1.5*10^9/L, platelets>=80*10^9/L, hemoglobin>=100g/L, AST and ALT=60ml/min or creatinine(Cr)<=1.5*ULN; 6. The patient with normal immune function; 7. Female: Women of childbearing potential must use an approved contraception and must have a negative serum or urine pregnancy test at screening, and must not be breast-feeding; 8. Male: Must be surgically sterile or compliant with an adequate contraception during, and for 3 months after the treatment; 9. Patients compliance with follow-up is required; 10. Ability to understand and the willingness to sign a written informed consent form, the signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Drug addiction or alcohol dependence; 2. Received any other investigational agents or non-approved drugs within 4 weeks preceding the first dose of investigational product; 3. Having following diseases or conditions: Newly diagnosed CNS metastases without surgery; Any serious, uncontrolled or unstable systematic diseases (including, but not limit to, active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases); History of neurologic or psychiatric disorders, etc.; 4. Any concurrent anti-tumor therapy during the study; 5. Pregnant or breast-feeding women; 6. Any other reasons rationalized by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor volume;Side effect;Pathologic Diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life; | — |
Countries
China
Contacts
Public ContactZhao Zijian
Guangzhou Sinogen Pharmaceutical Co.Ltd
Outcome results
None listed