advanced gastric cancer and colorectal cancer
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients are diagnosed as pancreatic cancer, gastric cancer, non-small cell lung cancer or colorectal cancer in cytodiagnosis or tissue diagnosis; 2. Patients show no response or relapse after a general standard chemotherapy; 3. Aged 18-75 years old; 4. Performance Status score of 0-2 according to the Eastern Cooperative Oncology (ECOG) scale; 5. Patients who are expected to survive for more than 3 months from the date of first administration; 6. With at least one measurable lesion via the RECIST criteria; 7. No abnormality of hematological system?liver or renal function, the examination be guaranteed as below: ANC>= 1500/mm^3, Platelets>=75,000/mm^3, Hgb>=10g/l, AST/ALT<=the upper limit of normal value, TBIL<= the upper limit of normal value, Cr<= 1.5 times upper limit of normal value; 8. Patients must not have received anticancer treatment such as radiation treatment?chemotherapy or targeted therapy within 4 weeks when enrolled in the trial; 9. Capable of giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients that have previously received the treatment of CPT or analogues; 2. Pregnant women or lactating women; 3. Patients suffer from myocardial diseases that show significant symptoms, e.g. history of symptomatic ventricular arrhythmia or congestive heart failure, or history of cardiac infarction within 12 months prior to enrollment; 4. Patients suffer from active bleeding or de novo thrombus, concurrent use of anticoagulant, or have the history of hemorrhagic tendency; 5. Patients with active upper gastrointestinal ulcer; 6. Patients with serious infectious diseases or metabolic dysfunction; 7. Patients suffer from active viral hepatitis or other liver diseases; 8. Patients with the history of other malignant tumor (with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix that achieve CR); 9. Patients with metastatic encephaloma; 10. Concomitant use of any drug label-indicated for tumor (including TMC and immunomodulators, etc); 11. Patients that have participated in other clinical trials within 30 days before enrolled in the trial. 12. Patients with mental disorder, or could not give written informed consent; 13. Other conditions that in the investigator's opinion preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR; | — |
Countries
China
Contacts
Public ContactJin Li
Fudan University Shanghai Cancer Center
Outcome results
None listed