locally advanced colorectal cancer
Conditions
Interventions
Experimental group (fruquintinib and CAPEOX):None
Sponsors
Jingzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the informed consent for this study; 2. Age 18-75 years old (including 18 and 75 years old); 3. Colorectal adenocarcinoma confirmed by histology and staging as stage II (T3-4N0) or stage III (T1-4N1-2) by MRI and CT; 4. Neoadjuvant therapy and surgery were recommended after multidisciplinary oncology committee evaluation; 5. ECOG performance status 0-1; 6. Expected survival =2 years; 7. Had not received any previous anti-tumor treatment; 8. At least one measurable lesion was required. (Response evaluation criteria in Solid Tumors, RECIST, version 1.1) 9. Vital organ function meets the following requirements (no use of blood components and cell growth factors within *14 days before enrollment) : Absolute neutrophil count =1.5×109/L; Platelet count =100×109/L; Hemoglobin =90g/L; Total bilirubin < 1.5× ULN; ALT and/or AST < 2.5× ULN; Serum creatinine < 1.5× ULN; Endogenous creatinine clearance =50ml/min; 10. Women of childbearing age need effective contraception; 11. Good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Inability to adhere to the study protocol or study procedures; 2. Patients with surgical contraindications; 3. Patients with metastatic disease or recurrence; 4. Patients with familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis; 5. Known DPD deletion; 6. Patients with other malignant tumors within 5 years before enrollment, except skin basal cell or squamous cell carcinoma after radical operation, or cervical carcinoma in situ; 7. Severe cardiovascular disease including unstable angina or myocardial infarction within 6 months before enrollment; 8. Subjects allergic to the study drug or any of its adjuvants; 9. Participated in clinical trials of other drugs which are not yet approved or marketed in China and received treatment with corresponding drugs within 4 weeks before enrollment; 10. International normalized ratio (INR) >1.5×ULN or partial activated prothrombin time (APTT) > 1.5×ULN; 11. Clinically significant Electrolyte abnormalities judged by the investigator; 12. Drug-uncontrolled hypertensions: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 13. Poorly controlled diabetes before enrollment (fasting glucose =CTCAE grade 2 after formal treatment); 14. Have any diseases or conditions that affect drug absorption before enrollment, or patients cannot take drugs orally; 15. Prior to enrollment, patients had active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or other conditions that may cause gastrointestinal bleeding or perforation according to the investigator; 16. Severe active bleeding and hemoptysis within 3 months before enrollment (within 4 weeks; 5 mL of fresh blood) or a thromboembolic event (including a stroke event and/or transient ischemic attack) within 12 months; 17. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure (New York Heart Association (NYHA) classification> Grade 2 ); Ventricular arrhythmias requiring medical therapy; LVEF (left ventricular ejection fraction) 1×104 copies /mL or 2000 IU/ mL); known hepatitis C virus (HCV) infection and HCV RNA positive (> 1×103 copies /mL); 20. Unmitigated toxic effects of grade 1 or higher ( by CTCAE v5.0 )due to any previous anticancer therapy, excluding alopecia, lymphopenia, and grade 2 or lower neurotoxicity due to oxaliplatin; 21. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 22. Any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality where there is reason to suspect that the patient has a disease or condition that would be inappropriate for use of the study drug(e.g., having seizures requiring treatment), or that would affect interpretation of the study results, or place the patient at high risk, in the investigator's judgment; 23. Urine routine test showed urinary protein =2+, and 24-hour urinary p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete Response(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR) ;objective response rate (ORR);R0 resection rate;disease-free survival; | — |
Countries
China
Contacts
Public ContactZilong Zhang
Jingzhou Central Hospital
Outcome results
None listed