metastatic colorectal cancer
Conditions
Interventions
Experimental Group:Apatinb
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 18 years old; 2. Patients with advanced nodular and rectal adenocarcinoma (all other histological types excluded) confirmed by pathology (see Annex I); 3. Previously received = second-line standard chemotherapy and treatment failed; Definition of treatment failure: (1) Disease progression during treatment or disease progression within 3 months after the last treatment, with clear evidence of imaging or clinical progression; (2) Exit criteria due to inability to tolerate chemotherapy adverse events. The patients treated, according to the CTCAE 4.0 standard, the severity level of intolerable hematologic adverse events needs to reach above IV (platelet decline is above III) or non-hematologic adverse events reach grade III or above, and the researchers judge The subject was still unable to tolerate repeating the original regimen; 4. According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter (CT scan with a long diameter of =10 mm, CT scan with a short diameter of =15 mm, and a scan layer thickness of no more than 5 mm; Over-the-counter treatment); 5. ECOG physical status score 0~3 points (see Annex 2); 6. The estimated survival period is = 3 months; 7. The main organs function well, that is, the following requirements are met one week before enrollment: (1) Blood routine examination: Hemoglobin > 80 g/L (no blood transfusion within 14 days); Neutrophil count >1.5×10^9/L; Platelet count >80×10^9/L; (2) Biochemical examination: Total bilirubin = 1.5 × ULN (upper normal limit); ALT or ALT = 5 × ULN; Endogenous creatinine clearance = 50 ml/min (Cockcroft-Gault formula); 8. Subjects received damage from other treatments, including nitroso or mitomycin at odds of =6 weeks; other cytotoxic drugs, radiation or surgery =4 weeks, and wounds Completely healed; 9. Sign the informed consent form; 10. Compliance is good, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Have multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 2. Have a history of hemorrhage, any serious grading of 4 degrees or more in CTCAE 4.0 within 4 weeks before screening; 3. Patients with high blood pressure who are not well controlled by a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); those with a history of unstable angina pectoris; newly diagnosed with angina within 3 months prior to screening Cardiac infarction occurred within 6 months before screening; arrhythmia (including QTcF: male = 450 ms, female = 470 ms) requires long-term use of antiarrhythmic drugs and New York Heart Association grade = grade III cardiac insufficiency; 4. Urine routine indicates urinary protein = +++ and confirmed 24-hour urine protein quantitation > 4.0 g; 5. Long-term unhealed wounds or incompletely fractured fractures; 6. Imaging shows that the tumor has invaded the important perivascular circumference or that the patient's tumor has a high probability of invading the important blood vessels during the treatment period and causing fatal bleeding; 7. Coagulation dysfunction, with bleeding tendency (must be satisfied 14 days before randomization: INR is within normal range without anticoagulant); anticoagulant or vitamin K antagonist such as warfarin, Patients treated with heparin or its analogues; small doses of warfarin (1 mg orally, once daily) or low-dose aspirin are allowed for prophylactic purposes, provided that the international normalized ratio (INR) of prothrombin time is = 1.5. Do not exceed 100 mg per day); 8. For female subjects: should be surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment and 6 months after the end of the study treatment period; before the study was enrolled The serum or urine pregnancy test must be negative within 7 days and must be non-lactating. Male subjects: should be surgically sterilized, or consent to use a medically approved contraceptive during the study treatment and within 6 months after the end of the study treatment period. 9. Persons with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 10. Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 11. According to the investigator's judgment, there are serious concomitant diseases that compromise the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| os;DCR;orr; | — |
Countries
China
Contacts
Public ContactShubin Wang
Peking University Shenzhen Hospital
Outcome results
None listed