advanced colorectal cancer
Conditions
Interventions
Experimental group:Take the Spleen Aminopeptide Oral Lyophilized Powder
Control group :Take placebo
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Diagnosed as advanced colorectal cancer by pathology and/or histology; Clinical stage IIIB~IV; 3. There is at least one objective measurable tumor lesions (imaging: CT, MRI), evaluable lesions can be accurately measured, the largest diameter = 10mm; 4. ECOG 0-2; 5. Expected survival period =12 weeks; 6. Agreed to participate in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Serum total bilirubin is 1.5 times higher than the upper limit of normal reference range; 2. ALT, AST, or ALP is 2.5 times higher than the upper limit of the normal reference range when no liver metastases; in liver metastasis, ALT, AST or ALP is 5 times higher than the upper limit of the normal reference range; 3. Serum creatinine > normal upper limit of 1.5 times 4. The toxic response has not been restored to level 1 after previous anticancer treatment (except hair loss); 5. Chemotherapy drugs or immuno-enhancement drugs have been used in the last 1 months. 6. Brain metastases or spinal cord compression without surgery and/or radiotherapy, or previously treated brain metastases or spinal cord compression but no clinical radiographic evidence suggests that the condition is stable for more than 14 days; 7. Other malignant tumors of the past or present (except for other malignancies with complete remission (CR) >5 years); 8. Previous history of nephrotic syndrome; 9. Inability to take oral medications, previous surgical history or severe gastrointestinal disorders such as dysphagia, the researchers believe may affect the absorption of research drugs; 10. The history of liver disease with significant clinical significance is known, including viral or other hepatitis or cirrhosis; 11. Patients who are pregnant, breastfeeding or judged not to have adequate contraceptive measures, including male patients; 12. The investigators consider that the patient's compliance with this clinical study is inadequate; 13. A person with a history of uncontrollable mental illness; 14. Have participated in clinical trials of other drugs in the past 30 days; 15. The patients that have severe, uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc. can not tolerate chemotherapy; 16. Any other disease, metabolic abnormalities, abnormal physical examination and laboratory abnormalities, according to researchers, there is reason to suspect that the patient has a disease or condition unsuitable for the use of the research drug, or that it will affect the interpretation of the findings, or to make patients at high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The quality of life improvement on the 42nd day; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;Effective rate of clinical symptoms;DCR;CD3, CD4, CD8;Tumor Markers;BMI index;The quality of life improvement on the 21st day;The quality of life improvement on the 84th day; | — |
Countries
China
Contacts
Public ContactCao Bangwei
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed