Colorectal cancer
Conditions
Interventions
Experimental group:mFOLFOXIRI + Camrelizumab + Bevacizumab
Sponsors
Peking University Shougang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, male or female; 2. Patients with histologically-confirmed diagnosis of local advanced rectal adenocarcinoma; 3. Patients with T3-4N0M0 and/or T1-4N+M0 and MRF(-) were determined by combining the results of pelvic and liver enhanced MRI and chest and abdomen enhanced CT; 4. The distance between the lower margin of the tumor and the anal margin judged by Pelvic MRI was = 1 year; 10. The function of major organs is normal, without immune deficiency diseases and serious dysfunction of blood, heart, lung, liver, kidney and bone marrow: (1) The laboratory tests met the following requirements: 1) Hb >= 90 g/L; 2) WBC >= 3.5 x 10^9/LL; NEUT >= 1.5 x 10^9/L; 3) PLT >= 90 x 10^9/L; 4) SCr = 50 ml/min; 5) TBIL = 2+, 24-hour urine protein quantification must be = 2 weeks from the beginning of the study; 12. Female subjects of non-surgical sterilization or childbearing age will be required to use a medically approved contraceptive device (such as an intrauterine device, birth control pill, or condom) during the treatment and within 180 days after the end of the treatment; non-surgically sterilized female reproductive age subjects need to be negative for serum HCG within 72 h prior to randomization and need to be non-lactatig; male subjects whose partner is a woman of reproductive age should use an effective method of contraception during treatment and within 180 days after the end of the treatment; 13. The subjects participated in the study voluntarily, fully understood and informed the study and signed the informed consent; 14. Agree to provide formalin fixed paraffin-embedded tumor tissue sections for specific biomarker association studies; 15. Agree to provide blood samples for specific biomarker association studies; 16. Patients are expected to have good compliance and can follow up the efficacy and adverse reactions according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Other malignancies were diagnosed within 5 years prior to first use of the study drug; the exceptions are effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or effectively resected cervical carcinoma in situ and/or breast cancer; 2. The patient has any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism [except patients with stable hormone levels after treatment]); subjects with complete remission of childhood asthma and do not require medical ntervention in adulthood or vitiligo may be included, but not those requiring medical intervention with bronchodilators; 3. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection method) or co-infection with hepatitis B and C; 4. Use of immunosuppressive drugs within 14 days prior to initial use of the study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisolone or other corticosteroids at pharmacophysiological equivalent doses); 5. Live vaccine is administered within 4 weeks prior to initial administration or planned during the study period; 6. Patients with hypertension who can not be reduced to the normal range by antihypertensive medication (systolic blood pressure 3 times; (5) Chronic diarrhea with a history of extensive small bowel resection; (6) History of refractory peptic ulcer within 3 months; 8. Bleeding, coagulation and anticoagulant drugs: (1) Bleeding (including hemoptysis) or coagulation disorders; (2) Warfarin, aspirin, low molecular weight heparin and other Chinese and western antiplatelet agglutination drugs are being used; 9. Patients with uncontrolled cardiac clinical symptoms or diseases, such as NYHA class II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, poorly controlled arrhythmias; 10. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity; 11. Patient with active tuberculosis; 12. Severe infection (e.g., requiring intravenous antibiotic, antifungal, or antiviral) within 4 weeks prior to initial administration, or unexplained fever >= 38.5 degrees during screening/prior to initial administration; 13. Previous allogeneic stem cell or solid organ transplantation; 14. History of allergy to the drug components of this regimen; 15. There is a possible increased risk of study participation and study medication or other severe, acute and chronic diseases; 16. Major surgery or open wound or fract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Margin-free (R0) resection rate;3y-OS (overall survival);3y-DFS (disesease free survival);QOL (quality of life);mrTRG (MRI-tumor regression grade);Safety;Bowel and sexual functions;Distant metastasis-free survival rate; | — |
Countries
China
Contacts
Public ContactGu Jin
Peking University Shougang Hospital
Outcome results
None listed