Rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient: 18-75 years old; 2. The preoperative biopsy case is diagnosed as rectal cancer; 3. Imaging examination indicates that the tumor infiltration depth T3-4 or (and) any T N1-2 is not accompanied by distant metastasis; 4. Middle and low rectal cancer, the lower edge of the tumor is = 6 months; 8. The main organs function normally; 9. Sign the informed consent form; 10. Compliance is good, and the family agrees to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received anti-VEGF or EGFR drugs; 2. TME surgery contraindications; 3. Participated in other drug clinical trials within four weeks; 4. Have multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 5. Those who have high blood pressure and are not well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 6. Urine routine indicates that urine protein >= ++ and confirmed 24-hour urine protein quantitation > 1.0 g; 7. Unhealed wounds or incompletely fractured fractures; 8. Coagulation dysfunction, with bleeding tendency (must be satisfied 14 days before randomization: INR is within normal range without anticoagulant); use anticoagulant or vitamin K antagonist such as warfarin, Patients treated with heparin or its analogues; use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin for prophylactic purposes, with an international normalized ratio (INR) of 1.5 for prothrombin time (Do not exceed 100 mg per day); 9. In the past year, the occurrence of hyperactive/venous thrombosis, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for those who have recovered from venous catheterization due to previous chemotherapy) and pulmonary embolism; 10. For female subjects: should be surgical sterilization, postmenopausal patients, or consent 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. 11. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 12. Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 13. At the discretion of the investigator, 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 |
|---|---|
| Objective response rate;Tumor regression grade; | — |
Countries
China
Contacts
The First Affiliated Hospital of Suzhou University