colorectal cancer
Conditions
Interventions
A:Thymalfasin Alpha-1 and raltitrexed
B:raltitrexed
Sponsors
Shanghai EAST Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years old; 2. Pathology confirmed advanced colorectal cancer with at least one measurable lesions according to RECIST 1.1; 3. The second line chemotherapy failure; 4. Eastern Co-operative Group (ECOG) performance status 0-2; 5. Estimated life expectancy =3 months; 6. Full recovery from any prior surgical procedure(s) and from reversible side effects of prior therapy for cancer including radiation therapy, chemotherapy, small molecule therapeutics and immunotherapy; 7. Adequate haematological, hepatic and renal functions: Absolute neutrophil count (ANC) = 1.5x 10^9/L; Platelet counts = 80 x 10^9/L; Haemoglobin = 90 g/L; Creatinine clearance > 65 mL/min Cr=1ULN; AST, ALT = 1.5 x Upper Limit of Normal Value (ULN) (= 5 x ULN in case of liver metastasis); Bilirubin < 1.5 x ULN; 8. Negative serum pregnancy test at screening in women of childbearing potential within 7 days prior the enrollment; 9. Signed written Informed Consent Form; 10. Willingness and ability to comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. History of other malignancy within 5 years,with the exception of cured non-melanoma skin cancers or cervix; 2. Pregnant or lactating women; 3. Previous treatment of raltitrexed injection as chemotherapy; 4. Immune drugs or medical technology of treatment with 6 months(including but not limited to the following: hymalfasin Alpha-1, thymopentin, interferon, etc.); 5. Treatment of PD-1/PD-L1 or CAR-T within 12 months; 6. Known brain metastases, meningitis, cancer, spinal cord compression or screening CT or MRI examination revealed cerebral pia mater or disease; 7. Electrocardiogram (ecg) obvious exceptions or clinical symptoms of heart disease, congestive heart failure, symptoms of coronary heart disease, drug is difficult to control arrhythmia, or 12 months had a myocardial infarction or coronary artery/peripheral artery bypass surgery or cardiac function grade III or IV; 8. Has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 9. Involvement in another therapeutic clinical trial within 4 weeks; 10. Known ascites; 11. Local treatment requirement of metastatic lesions at the same time, such TACE to the liver, radiotherapy to the pulmonary metastases , etc.; 12. Known pulmonary interstitial change; 13. Concomitant diseases which will seriously endanger the safety of patients or to completed the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;QoL; | — |
Countries
China
Contacts
Public ContactJin LI
Shanghai East Hospital
Outcome results
None listed