colorectal cancer
Conditions
Interventions
Prevention Group:Take Regofini
Controlled Group:Take other anti-tumor drugs
Sponsors
Maoming People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with metastatic colorectal cancer have progressed or failed to meet the standard treatment, such as fluorouracil, oxaliplatin, irinotecan, endothelial growth factor (VEGF) inhibitors (such as bevacizumab) and anti-EGFR antibodies (if applicable), but they are suitable for the treatment of repaglinide. 2. Patients with diseases that can be biopsied can be measured by X-rays. 3. Patients with a performance score of 0 or 1 in the Eastern Cancer Cooperative Group (ECOG). 4. Older than 18 years old. 5. Life expectancy is at least 12 weeks (3 months). 6. Subjects must be able to understand and be willing to sign written informed consent. Prior to any specific test procedure, a signed informed consent form should be properly obtained. 7. Adequate bone marrow, liver, and kidney functions assessed according to the following laboratory requirements: 7.1 Total bilirubin is less than 1.5× upper limit of normal value (ULN) 7.2 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5×ULN (less than 5×ULN for subjects with liver cancer). 7.3 The limit of alkaline phosphatase is less than 2.5×ULN (less than 5×ULN for subjects with liver cancer). 7.4 Serum creatinine is less than 1.5×ULN. 7.5 For subjects with liver metastasis, AST and ALT less than 5×ULN are the normal upper limit of the normal range of the institution, and non-fasting bilirubin less than 1.5-3.0×ULN is acceptable. 8. Fertile women must have a negative serum pregnancy test within 7 days before the start of the study drug. Postmenopausal women (defined as women who have not had menstruation for at least one year) and women who have undergone surgical sterilization do not need to have a pregnancy test. Fertile subjects (male and female) must agree to start using enough contraceptives when signing ICF until at least 3 months after the last dose of the study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or designated assistant, but it is usually defined as hormonal or barrier contraception or abstinence. 9. Subjects must be able to swallow and keep oral drugs.
Exclusion criteria
Exclusion criteria: 1. Despite the best medical management, hypertension has not been controlled (systolic blood pressure > 140mmhg or diastolic blood pressure > 90mmhg). 2 active or clinically significant heart diseases, including: 3. Congestive heart failure-New York Heart Association (NYHA) > Grade II. 4. Active coronary artery disease. 5. Arrhythmias that require antiarrhythmic treatment other than beta blockers or digoxin. 6. Unstable angina pectoris (angina symptoms at rest), new angina pectoris within 3 months before random grouping or myocardial infarction within 6 months before random grouping. 7. Evidence or history of hemorrhagic quality or coagulopathy. 8. Start to study any bleeding or bleeding events within 4 weeks before drug treatment, NCI CTCAE level 3. 9. Patients with pheochromocytoma. 10 known history of human immunodeficiency virus (HIV) infection or chronic or active hepatitis B or C infection that currently requires antiviral treatment. 11. Persistent infection is greater than grade 2 NCI-CTCAE version 4.0. 12. There are unhealed wounds, unhealed ulcers, or fractures. 13. Renal failure requiring hemodialysis or peritoneal dialysis. Interstitial lung disease with persistent signs and symptoms at the time of informed consent. 15. Pleural effusion or ascites that causes respiratory damage (NCI-CTCAE version 4.0, grade 2 dyspnea). 16. History of organ transplantation (including corneal transplantation). 17. Known or suspected allergic or hypersensitive reactions to any study drug, study drug category, or preparation excipient given in this experiment. 18. Any malabsorption. 19. Pregnant or breastfeeding women. 20. Any circumstance that the researcher thinks makes the subject unfit to participate in the trial. 21. Substance abuse, medical, psychological, or social conditions that may interfere with the participant's participation in the research or evaluation of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved complete remission (CR) at the 8th week and partial remission (PR) at any time and stable disease (SD) at any time.;Partial response;complete response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of days from research entry to progress or death; Patients who are still alive and have no progress at the end of follow-up will be examined on that day.;The number of days from study to death; Patients who are still alive at the end of the follow-up will be examined on that day. All deaths are included.;Percentage of subjects who experienced unacceptable (grade 3/4) adverse events; describe the safety profile.; | — |
Countries
China
Contacts
Public ContactYating Hou
Maoming People's Hospital
Outcome results
None listed