colorectal cancer
Conditions
Interventions
experimental group:S-1 and raltitrexed
Sponsors
Department of Medical Oncology, Cancer Center, The State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The eligibility criteria were as follows:presence of unresectable, metastatic, and histologically confirmed colorectal cancer; age>=18 years old; estimated life expectancy of >=12 weeks; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero to two; disease progression after treatment with irinotecan and oxaliplatin containing regimens; patients were at least 2 weeks away from the end of chemotherapy, and 4 weeks after radiotherapy,and the lesion is observed in the non radiotherapy target area; at least one unidimensionally measurable lesion as assessed by spiral computed tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1); adequate hematological, renal, and hepatic functions, as defined by haemoglobin >=90g/L, platelet count >=75*10^9/L, white blood cell count>=3.0*10^9 or absolute granulocyte count>=1.5*10^9/L, serum bilirubin level<=1.5*upper limit of normal(ULN), serum creatinine level<=1.5*ULN, and aspartate aminotransferase/alanine aminotransferase less than or equal to 2.5*ULN (if related to liver metastasis, ALT and AST<=5*ULN); informed consent from all patients was obtained before enrolment; without consideration of combined use of targeted agents in chemotherapy; patients with a previous history of chemotherapy not including S-1 or raltitrexed.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had severe liver and kidney dysfunction; or the recent history of myocardial infarction(within 3 months); other active malignancies(unless skin basal cell carcinoma or situ carcinoma of cervix); brain metastasis or nervous system is oppressioned; serious uncontrolled medical disease or acute infection (infection caused more than 38 degrees Celsius fever); combined with severe internal and external diseases,which affects organic function; pregnant or lactating women or fertility of (male or female menopause less than 1 year) patients are not willing to take contraceptive measures; patients with chronic diarrhea, or complete intestinal obstruction; allergic to S-1 and raltitrexed; the researchers think the patient is not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression - free survival;tumor objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;quality of life; | — |
Countries
China
Contacts
Public ContactLiu Jiyan
Outcome results
None listed