high-risk patients with resectable colorectal liver metastases
Conditions
Interventions
experimental group:CAPOX+PD-1+Bevacizumab
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign an informed consent form for this study, and comply with the requirements and evaluation schedule of this study; 2. be of either sex, 18-75 years of age; 3. any RAS/BRAF mutation. 4. MSS/pMMR type 5. ECOG 0 - 2 ; 6. pathologically confirmed high-risk resectable colorectal liver metastases that meets the following criteria: Definition of resectable: ? only liver metastasis ? number of metastatic tumors =6 ? Technically resectable (judged by MDT of the research center) Definition of high-risk recurrence factors: CRS =3 7. Physical condition and organ function allow to undergo larger abdominal surgery; 8. major organ function meets the following requirements (laboratory test values within 7 days prior to enrollment must meet the following criteria) ? routine blood tests: (no blood transfusion, use of granulocyte colony-stimulating factor, or drug correction within 14 days before screening): a) neutrophils = 1.5 × 109/L; b) platelets = 75 × 109/L; c) hemoglobin = 90g/L ? Biochemical tests: (no albumin infusion within 14 days prior to screening): a) blood creatinine = 1.5 × upper limit of normal (ULN), or creatinine clearance > 50 mL/min; b) serum total bilirubin = 1.5 × ULN; c) albumin transaminase (AST), alanine transaminase (ALT) = 2.5 × ULN Coagulation function: a) International normalized ratio (INR) =2.3 or prothrombin time (PT) =6 seconds above the range of normal control
Exclusion criteria
Exclusion criteria: 1. Present or previous active malignant tumor other than colorectal cancer; 2. Present or previous treatment with any other form of antitumor therapy; 3. Major surgical treatment within 4 weeks prior to the start of study treatment; 4. The presence of any condition that interferes with the absorption of bevacizumab in the gastrointestinal tract; 5. The presence of serious uncontrolled recurrent infections, or other serious uncontrolled concomitant medical conditions; 6. Allergic to any test drug and its excipients, or has a history of severe allergy; 7. Have a serious concomitant medical condition that life expectancy < 3 months; 8. Present or previous moderate or severe hepatic or renal impairment; 9. Have received allogeneic bone marrow transplant or organ transplant before and undergoing; 10. Patients with congenital or acquired immunodeficiency (e.g., HIV-infected); 11. Patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, the clinical severity of which, in the judgment of the investigator, would preclude the signing of an informed consent form or interfere with the patient's adherence to oral medications 12. Patients who, in the judgment of the investigator, have other factors that may affect the results of the study or cause this study to be forcibly terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) that require comorbid treatment, serious laboratory test abnormalities, concomitant familial or social factors, etc., that would compromise the safety of the patient; 13. Women who are pregnant or breastfeeding 14. Other conditions that are assessed by the investigator to be unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0/R1 resection rate ;one-year progression-free survival rate ,1-y PFS rate;Safety and postoperative complications;QLQ-C30; | — |
Countries
China
Contacts
Public ContactWensheng Qiu
The Affiliated Hospital of Qingdao University
Outcome results
None listed