colorectal cancer
Conditions
Interventions
test team:Capecitabine combined with apatinib
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. to issue an informed consent prior to the conduct of any particular process of study; 2. male or female aged 18-75 years; 3. Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology; 4. Patients who had not previously been exposed to apatinib and who had received oxaliplatin combined with fluorouracil chemotherapy; 5. The estimated survival time will be more than 3 months; 6. the score of ECOG was 0 or 1; According to RECIST v1.1 guidelines, at least one lesion (no previous radiotherapy). At baseline, the longest diameter = 10 mm (except lymph nodes) was accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (the preferred intravenous contrast medium). The short axis of lymph node must be more than 15mm, and the lesion is suitable for repeated accurate measurement. If the lesion located in the previously irradiated area clearly proves to be progressive, the lesion can be used as a measurable lesion; 7. adequate organ and bone marrow functions are defined as follows: Hemoglobin = 9 g/dL Absolute neutrophil count = 1.0×10^9/L Platelet count = 75×10^9/L Total serum bilirubin = 1.5 × normal upper limit is not suitable for Gilbert syndrome (persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin). Patients with no evidence of hemolysis or abnormal liver pathology) may consult a doctor; ALT and AST = 2.5×ULN; for patients with liver metastasis, ALT and AST = 5×ULN Creatinine clearance calculated using Cockcroft-Gault formula (using actual body weight). Or the creatinine clearance calculated by measuring 24 hours urine samples was more than 40 mL / min. (if both methods were used. The values measured using 24-hour urine collection will be used to determine eligibility) Women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days of admission. The results were negative and willing to use appropriate methods of contraception during the trial and within 6 months after the last administration of the experimental drug. For men who agreed to take the appropriate prescription during the trial and 6 months after the last administration of the experimental drug. -legal contraception; Patients voluntarily participate in the trial and sign informed consent, good compliance.
Exclusion criteria
Exclusion criteria: Patients with hypertension who could not be reduced to normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg / DBP > 90 mm Hg); Patients with coronary heart disease = grade II, arrhythmia (including prolonged QTc interval > 450msin males and females > 470ms) and cardiac insufficiency; There are many factors affecting oral medicine (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); Special attention: patients at risk of gastrointestinal bleeding should not be included in the group, including those with active peptic ulcer lesions and stool occult blood + +; Those who had a history of black stool and hematemesis within 3 months; For stool occult blood + +) and primary gastric neoplasms have not been surgically resected, gastroscopy must be performed, such as ulcerative gastric cancer, which is considered by the doctor to be likely to cause bleeding. (4) the patients with abnormal coagulation function (INR > 1.5 × ULNN APTT > 1.5 × ULNN) had a tendency to bleed. Patients with symptomatic central nervous system metastasis; Pregnant or lactating women; Other physicians do not consider it appropriate to include patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| size of the lesions; | — |
Countries
China
Contacts
Public ContactYanqiao Zhang
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed