colorectal cancer
Conditions
Interventions
Case series:Mesylate Apatinib
Sponsors
Affiliated Tumor Hospital of GuangXi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old; 2. ECOG PS: 0-2 points; 3. Colorectal cancer diagnosed by histology; 4. Imaging examination revealed metastatic lesions in the liver, and the diagnosis was unresectable; 5. Have not received systematic treatment before; 6. The estimated survival time is more than 3 months; 7. Baseline blood routine and biochemical indicators meet the following criteria: Hemoglobin is greater than 90g/L. The absolute number of neutrophils (ANC) is greater than1.5x10^9/L. Platelet is greater than 90x10^9/L ALT, AST is less than 5xULN or less Serum total bilirubin was less than 1.5xULN. Serum creatinine is less than 1.5xULN. Serum albumin is greater than 30g/L. 8. Female subjects: should use surgical sterilization,or postmenopausal patients, or or consent to adopt a medically approved method of contraception within 6 months after the end of the research and treatment period;The serum or urine pregnancy test must be negative within 7 days before the study, and must be non-lactation. Male subjects: should be sterilized for surgery, or consent to adopt a medically approved method of contraception within 6 months after the end of the research and treatment period; 9. The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Had other malignant tumors in the past or at the same time, except the treated skin basal cell carcinoma and cervical carcinoma in situ; 2. Various factors that affect oral drugs (such as unable to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Patients with a clear tendency of gastrointestinal bleeding. Includes the following situations: hemorrhage with local activity, and fecal occult blood (++); Patients with hemafecia and hematemesis in 2 months; The researchers suggest that he/she may happen massive alimentary tract bleeding; 4. Patients who have been known to have central nervous system metastasis or have a history of central nervous system metastasis before screening. For patients with suspected CNS metastasis, CT or MRI examination must be performed within 28 days , and the central nervous system should be excluded. 5. People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-i above coronary heart disease, arrhythmia in class I (> 450 ms, including QTc lengthened men women > 470 ms) and the grade I cardiac insufficiency; 6. The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantitative >1.0 g; 7. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency (14 days before randomization must be met: INR is within normal range without anticoagulant); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues;under the premise of 1.5 or less International standardization in prothrombin time ratio (INR), allowing purpose to preventive using low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 8. Move/vein thrombosis incidents happened in the year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except line by chemotherapy venipuncture vein thrombosis by researchers who have judgment recovered ) and pulmonary embolism, etc.; 9. Participated in other drug clinical trials in four weeks; 10. Having a history of psychotropic substance abuse and being unable to quit or have mental disorders; 11. The history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or the history of organ transplantation; According to the researchers' judgment, there are serious diseases that endanger patients' safety or affect patients' complete research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;AE; | — |
Countries
China
Contacts
Public ContactXianwei Mo
GuangXi Medical University Affiliated Tumor Hospital
Outcome results
None listed