Advanced colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic colorectal cancer confirmed by pathology; 2. Have at least one evaluable lesion (refer to RECIST 1.1); 3. Patients who progress after second-line standard chemotherapy (patients who cannot tolerate chemotherapy toxicity can also be enrolled). 4. Age 18 years old or above, male or female; 5ECOG PS: 0-2 points; 6. Estimated survival time = 12 weeks; "7. The main organ function levels meet the following criteria: 1) Blood routine examination criteria should be consistent with: ANC=1.5×109/L, PLT=80×109/L, Hb=90g/L (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli) ); 2) Biochemical examination should meet the following criteria: TBIL<1.5×ULN, ALT, AST<2.5×ULN, ALT, AST can be <5×ULN, BUN and Cr=1×ULN or endogenous creatinine clearance = 50ml/min (Cockcroft-Gault formula);7" 8. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative and willing to use appropriate during the trial and 8 weeks after the last administration of the test drug. Method of contraception. 9.Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade II arrhythmia (including QTc interval prolongation) >470 ms) and grade II cardiac insufficiency; 2. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 3. Patients with a clear tendency to bleed; 4. Imaging shows that the tumor has invaded important blood vessels or that the patient's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding; 5. Have HIV infection or a patient; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 7. Patients with positive urine protein; 8. Patients with active brain metastases; 9. Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cells or squamous epithelial skin cancer); 10. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 11. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study; 12. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective remission rate;Quality of Life; | — |
Countries
China
Contacts
Daping Hospital, Army Medical University