Colorectal cancer
Conditions
Interventions
Experimental group:Endostar combined with FOLFOX
Control group:FOLFOX
Sponsors
Daping Hospital, Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patiens with a pathological diagnosis of stage IV advanced colorectal cancer and have undergone initial or retreatment .(MIa or MIb according to the 8th edition of the TNM staging system); 2. Must have at least one evaluable lesion as judged by RECIST 1.1 criteria (The longest diameter on spiral CT at least 10mm, the longest diameter of ordinary CT at least 20mm); 3. APE1 immunohistochemistry karyoplasmic expressed as ++ or +++. ELISA detection of serum high expression; 4. Aged 18 to 75 years old; 5. Expected survival = 3 months; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2; 7. Haven't received any anti-cancer drug treatment, or previously had only received adjuvant or neoadjuvant chemotherapy for non-metastatic tumorsbut it has to finished more than 6 months before the treatment begins; 8. If patients have surgery in the past,before the treatment begins,the surgery must have finished over 4 weeks,and the patient was recovered; 9. The main organ function meeting the following items: (1) blood routine examination meeting the standards: HB=90g/L(no blood transfusion and blood components support within 14 days); ANC =1.5×10^9/L; PLT =80×10^9/L; (2) blood biochemical examination meeting the following standards: BIL 45ml/min (Cockcroft-Gault formula); 10. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 11. participants volunteered to participate in this study, signed informed consent, compliance, with follow-up. No serious allergic reaction to biological agents, especially E. coli genetic engineering products; 12. ECG is normal, no unhealed wounds on the body.
Exclusion criteria
Exclusion criteria: 1. No cytology or disease basis; 2. Brain metastases uncontrolled; 3. Have serious uncontrolled medical diseases,myocardial infarction in 3 months, Acute infection,Having a history of psychiatric abuse and can not quit or have mental disorders; 4. Have experience of other new drug clinical trials in 4 weeks; 5. Pregnant and lactating women; 6. Male patients with fertility requirements; 7. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 8. Hypokalemia,or periodic paralysis history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;QoL;drug safety; | — |
Countries
China
Contacts
Public ContactZhong Zhaoyang
Daping Hospital, Chongqing
Outcome results
None listed