rectal cancer
Conditions
Interventions
test group:No
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG performance status score of 0 or 1; 3. Expected survival time >= 6 months; 4. Diagnosed as colorectal adenocarcinoma by histopathological examination, with metastatic/recurrent lesions that cannot be cured by surgical treatment; 5. Within 4 weeks before randomization, at least 1 measurable lesion according to RECIST1.1 criteria 6. Patients who have received systemic anti-tumor therapy for mCRC in the past (including systemic chemotherapy, molecular targeted drug therapy, biological therapy, and other investigational therapeutic drugs, etc.), and the researchers believe that the patients can benefit from bevacizumab; 7. If the subject has undergone surgery in the past, medication must be administered six weeks after surgery; 8. Good organ function, meeting the requirements of the following laboratory test values: Absolute neutrophil count (ANC)>= 1,500 /mm3 (1.5 x 10^9 /L); platelets >= 80,000 / mm3 (80 x 10^ 9/L); hemoglobin >= 9g/dL (no blood transfusion required within 2 weeks before screening); serum creatinine = 50 mL/min (calculated according to the Cockcroft-Gault formula , creatinine clearance formula: CCr (ml/min) = (men) (140-age) x body weight (kg)/72x serum creatinine (mg/dL); (women) (140- age) X body weight (kg)/ 85X serum creatinine (mg/dL) umol/Lx0. 01131=mg/dL); serum total bilirubin <= 1.5 x ULN (if there is liver metastasis, allow <= 2. 5 x ULN); AST (SGOT), ALT ( SGPT) and alkaline phosphatase (ALP) <= 3xULN (AST/ALT W less than or equal to 5xULN allowed if liver metastases are present; ALP <= 5 x ULN allowed if liver metastases and/or bone metastases are present); International Normalized Ratio (INR) ) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) <= 1.5 x ULN (if the subject is receiving anticoagulant therapy, as long as the PT or aPTT is within the expected therapeutic range for the use of anticoagulant drugs can); 9. The subjects had good compliance, signed the informed consent, and were able to cooperate with relevant inspections and follow-up.
Exclusion criteria
Exclusion criteria: 1. Received systemic therapy containing bevacizumab in the past; 2. Existing brain metastases or leptomeningeal metastases; 3. History of thrombotic disease within 6 months and/or hemoptysis within 3 months (coughing up at least 1/2 teaspoon of blood at a time); ongoing use of full-dose oral or parenteral anticoagulants or thrombolytics Treatment (prophylactic use of anticoagulants is allowed); use of aspirin (>325 mg/day) or other non-specific anti-inflammatory drugs that inhibit platelet function within 10 days before the first study drug administration. CT/MRI images show tumor encircling or Invasion of the lumen of a large vessel (such as the pulmonary artery or superior vena cava); 4. Poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg under regular drug control), and subjects with a history of hypertensive crisis or hypertensive encephalopathy; severe cardiovascular and cerebrovascular disease Disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis within 6 months prior to enrollment) form); unstable angina, New York Heart Association (NYHA) class >= II heart failure, and severe arrhythmia uncontrolled by medication; 5. Non-healing wounds, active peptic ulcers or fractures; tracheo-esophageal fistula, gastrointestinal perforation or gastrointestinal atrophy, and intra-abdominal abscess within 6 months; uncontrolled infection, including but not limited to: a . Known history of human immunodeficiency virus (HIV-1 or HIV-2) or syphilis infection, screen for HIV, syphilis according to local practice and local management guidelines b. Hepatitis B (HBcAb and/or HBsAg positive, and HBV DNA >= 1000 cps/mL or higher than the upper limit of detection value); c. Hepatitis C (HCV antibody) test result is positive; 6. Those who are known to be allergic to bevacizumab and its excipients; 7. Pregnant women and lactating women; women of childbearing age and male subjects, during the study period and within 6 months after the last administration of the study drug, cannot use effective contraceptive measures; 8. Other malignant tumors other than colorectal cancer within 5 years, excluding fully treated cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical resection and breast ductal carcinoma in situ; 9. Subjects who have participated in other clinical studies in the last 4 weeks (except those who only signed the ICF and withdrawn their knowledge without receiving any screening examination); 10. The researcher believes that there are other conditions that are not suitable for participating in this research; 11. Received intestinal stent implantation in the past, and the intestinal stent has not been removed by the screening period; 12. The primary lesion has not been removed and there is a history of intestinal obstruction within the past 3 months; 13. History of intraperitoneal implantation or infusion of chemotherapy drugs within 6 months, including but not limited to fluorouracil implants (China Fluan), raltitrexed, 5-FU, oxalibur, c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Economic evaluation; | — |
Countries
China
Contacts
Public ContactZhang Xiaojian, Zong Hong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed