metastatic colorectal cancer
Conditions
Interventions
Case series:raltitrexed with S-1
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged >=18 years; 2. patients with metastatic adenocarcinoma of the colon or rectum confirmed by histopathology or cytology; 3. estimated survival >=12 weeks; 4. ECoG score 0-2; 5. previous use of fluorouracil (intravenous and / or oral fluorouracil preparations are allowed, but DPD enzyme inhibitors are not included), irinotecan, oxaliplatin chemotherapy failure (definition of treatment failure: intolerable adverse reactions, disease progression during treatment or disease progression within 6 months after completion of adjuvant chemotherapy) for metastatic colorectal cancer; 6. patients voluntarily use a combination of raltitrexed and S-1, whether or not they have used targeted drugs such as cetuximab or bevacizumab in the past; 7. The patients were at least 2 weeks away from the last chemotherapy (more than 1 week after oral chemotherapy) or more than 4 weeks after radiotherapy, and the focus was observed in the non radiotherapy target area in this study; 8. According to the recist1.1 standard, there is at least one measurable objective tumor focus, the maximum diameter of which must be >=1cm by spiral CT; 9. laboratory test results within 1 week before enrollment meet the following conditions: Hemoglobin >=90g / L; platelet (PLT) >=75x10^9/L; WBC >=3.0x10^9/L, ANC >=1.5x10^9/L; Cr <=1.5 ULN; TBI <=1.5 ULN; ALT and AST <=2.5 ULN; No use of raltitrexed or S-1 (or DPD enzyme inhibitor) in the treatment of colorectal cancer. 10. allow combination of targeted or immunotherapy; 11. sign informed consent.
Exclusion criteria
Exclusion criteria: 1. patients who are unable to take orally; 2. evere hepatorenal insufficiency or recent history of myocardial infarction (within 3 months); 3. a history of other malignancies within five years, except for cured cervical carcinoma in situ and skin basal cell carcinoma; 4. patients who are unable to take orally; 5. Severe hepatorenal insufficiency or recent history of myocardial infarction (within 3 months); 6. a history of other malignancies within five years, except for cured cervical carcinoma in situ and skin basal cell carcinoma; 7. history of inflammatory bowel disease or extensive colectomy, 50% or extensive enterotomy with chronic diarrhea, intestinal obstruction; 8. people with serious uncontrolled medical disease or acute infection (infection causes fever above 38 ?); 9. symptomatic brain or meningeal metastasis (unless the patient is treated with brain or meningeal metastasis for more than 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to brain or meningeal metastasis are stable when entering the study); 10. hydrothorax and ascites which can not be controlled after clinical intervention; 11. pregnant or lactating women or fertile (men or women with menopause less than 1 year) are unwilling to take contraceptive measures; 12. persons known to be allergic to raltitrexed or S-1 and their ingredients; 13. patients judged by the investigator not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactLiu Ji-Yan
West China Hospital, Sichuan University
Outcome results
None listed