colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Colorectal cancer patients aged>18 years and= 12 weeks: 5. If the main organs function normally, they meet the following standards: 1) The blood routine examination standard should meet: ANC>1.5x109/L; PLT>90x109/L; Hb>90g/L (no blood transfusion within 14 days); 2) Biochemical examination shall meet the following standards: ALB>30g/L: (no ALB transfusion within 14 days); TBIL50mL/min (CockcrofGault formula); 3) Color Doppler echocardiography and echocardiography: left ventricular ejection fraction (LVEF>55%); 4) 18 lead ECG Fridericia corrected OT interval (OTcF)<470ms in women; 6. Female patients without menopause or surgical sterilization; During the treatment period and at least 7 months after the last administration in the study treatment, consent to abstinence or use of effective contraceptive methods; 7. Willing to join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received standard second-line treatment; 2. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 3. In the first 4 weeks of enrollment, he had undergone major surgical procedures unrelated to colorectal cancer. Or the patient has not fully recovered from such surgical procedures; 4. Serious heart disease or discomfort, including but not limited to the following diseases: 1) History of diagnosis of heart failure or systolic dysfunction (LVEF100bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (i.e. Mobitz ? second degree atrioventricular block or third degree atrioventricular block); 3) Angina pectoris requiring anti angina drugs; 4) Valvular heart disease with clinical significance; 5) ECG showed transmural myocardial infarction; 6) Hypertension was poorly controlled (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg). 5. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption; 6. People known to have a history of allergy to the drug components of this protocol: have a history of immune deficiency, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 7. Women in pregnancy and lactation, women with fertility and positive baseline pregnancy test, or women in childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study drug use; 8. Suffer from serious concomitant diseases or other concomitant diseases that will interfere with the planned treatment, or any other circumstances that the investigator believes the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Countries
China
Contacts
Xuchang Central Hospital