Rectal cancer
Conditions
Interventions
experimental group:apatinib mesylate combined with CapeOx neoadjuvant treatment
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Patients with rectal cancer diagnosed by pathology; 3. Patients with >= T3 or N+ rectal cancer, middle and low rectal cancer, the lower edge of the tumor is = 10 mm, lymph node lesions CT/MRI scan short diameter >= 15 mm, scan thickness Not more than 5 mm; and has not received local treatment) 8. The expected survival period is >= 3 months; 9. The main organs are functioning well, that is, the relevant inspection indicators meet the following requirements within 14 days before randomization: 1) Routine blood examination: a) Hemoglobin> 90 g/L; b) Neutrophil count > 1.5 x 10^9/L; c) Platelet count > 100 x 10^9/L; 2) Biochemical inspection: a) Total bilirubin = 60 ml/min (Cockcroft-Gault formula); 3) Heart Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%. 10. Women of childbearing age must take a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and And are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last trial drug administration; 11. Sign the informed consent form; 12. The compliance is good, and the family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of or concurrent malignant tumors (except skin basal cell carcinoma and carcinoma in situ); 2. Patients with hypertension who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure) Pressure > 90 mmHg), with coronary heart disease above grade I, grade I arrhythmia (including prolonged QTc interval > 470 ms) and grade I cardiac insufficiency; 3. There are many factors that affect oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal infarction); Resistance, etc.); 4. Patients with a clear bleeding tendency; 5. Clinical staging T4b stage rectal cancer patients, directly invading or adhering to other organs or structures; 6. Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patients tumor is extremely high during treatment; It may invade important blood vessels and cause fatal bleeding; 7. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 8. Patients with positive urine protein; 9. Those who have been confirmed to be allergic to apatinib mesylate tablets and/or its excipients; 10. Pregnant or lactating women; 11. Doctors believe that they are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| tumor regression grade,TRG;pathological complete response, pCR;pathological remission rate, pRR;Objective Response Rate, ORR;disease control rate, DCR;Adverse Event, AE; | — |
Countries
China
Contacts
Public ContactGang Wu
He'nan Provincial People's Hospital
Outcome results
None listed