Colorectal cancer
Conditions
Interventions
Experimental group:Furoquantinib combined with capecitabine and PD-1
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Aged 18-75 years (including 18 and 75 years); 3. It was histologically confirmed as colorectal adenocarcinoma with stage II (T3-4N0) or stage III (T1-4N1-2) by MRI and CT; 4. Recommended neoadjuvant therapy and surgery after evaluation by the multidisciplinary Cancer committee; 5.ECOG physical condition 0-1 score; 6. Expected survival =2 years; 7. Have not received any anti-tumor therapy before; 8. Must have at least one measurable lesion (solid tumor efficacy evaluation criteria, namely RECIST version 1.1); 9. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within *14 days before enrollment) : Absolute neutrophil count =1.5×109/L; Platelet =100×109/L; Hemoglobin =90g/L; Total bilirubin < 1.5 ULN; ALT and/or AST < 2.5 times ULN; Serum creatinine < 1.5 ULN; Endogenous creatinine clearance =50ml/min; 10. Women of childbearing age need to take effective contraceptive measures; Good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Failure to comply with the study protocol or study procedure; 2. Patients with surgical contraindications; 3. Patients with metastatic disease or recurrence; 4. Patients with familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), active Crohn's disease or active ulcerative colitis; 5. Known loss of DPD; 6. Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 7. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment; 8. Subjects who are allergic to the investigational drug or any of its adjuncts; 9. Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment; 10. International Normalized Ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN; 11. Electrolyte abnormalities identified by the investigator as clinically significant; 12. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 13. Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration =CTCAE level 2 after formal treatment); 14. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally; 15. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or other conditions determined by researchers that may cause gastrointestinal bleeding and perforation before enrollment; 16. Severe active bleeding, hemoptysis (>5 mL of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enrollment; 17. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade >2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) 1×104 copies /mL or >2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL); 20. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade =2 neurotoxicity; 21. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 22. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk; 23. Urine routine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response, pCR;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;R0 removal rate;DFS; | — |
Countries
China
Contacts
Public ContactTao Xu
Shandong Provincial Hospital
Outcome results
None listed