colorectal cancer
Conditions
Interventions
experimental group:Apatinib combined with FOLFIRI
Sponsors
Shanxi Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75, male and female; 2. Patients with locally advanced stage III or IV colorectal cancer (patients who can undergo surgery but need preoperative and postoperative chemotherapy); 3. At least one imaging examination can measure lesions (RECIST 1.1 standard). The target lesions of spiral CT or MR should be more than 10 mm and lymph nodes more than 15 mm; 4. ECOG physical condition score: 0-2; 5. The life expectancy is more than 3 months; 6. Blood routine examination was normal: A. WBC (> 3.5 *10^9/L); B. ANC (> 1.5 *10^9/L); C. HB (> 100 g/L); D. PLT (> 1 *10^10/L); Blood biochemistry meets the following criteria: In the absence of liver metastasis, ALT was less than 2.5 x ULN. If liver metastasis occurs, ALT is less than 5 *ULN. 8. Normal urine and stool routine (except for patients with urinary protein (> grade 2) and occult blood (++). 9. The wound healed completely without bleeding tendency. 10. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the drug. 11. Patients volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Complications such as intestinal perforation, massive intestinal pneumatosis or acute intestinal obstruction, severe infection, etc.. 2. Patients with hypertension whose systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg, coronary heart disease (> grade II), arrhythmia (including prolonged QTc interval in males > 450 ms, females > 470 ms) and cardiac insufficiency were unable to fall to the normal range after antihypertensive treatment (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg). 3. There are many factors affecting oral medicines (such as inability to swallow, chronic diarrhea and intestinal obstruction). 4. Patients who have received chemotherapy in the past; 5. Those with abnormal coagulation function and bleeding tendency; 6. Symptomatic central nervous system metastasis; 7. Pregnant or lactating women; Other doctors do not think it is suitable for patients to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival time (DFS);R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactBo Jiang
Shanxi Provincial Cancer Hospital
Outcome results
None listed