Colorectal cancer
Conditions
Interventions
experimental group 1:Camrelizumab
experimental group:bevacizumab / apatinib
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, both male and female; 2. Rectal adenocarcinoma diagnosed by histopathology, excluding anal squamous cell carcinoma; 3. Have not received any anti-tumor therapy for rectal cancer before. In the case of Lynch syndrome, no antitumor therapy has been done for the bowel cancer diagnosed at this time; 4. The local clinical staging of the rectum based on high-resolution pelvic MRI is: the lower edge of the tumor is within 10 cm of the anal verge, and the histologically confirmed T3-4N0M0 or T1-4N+M0 rectal adenocarcinoma patients, regardless of MRF and EMVI status. Enhanced CT of chest and abdomen showed no signs of distant metastasis (excluding lateral lymph nodes); 5. ECOG performance status score 0–1; 6. Has adequate organ and bone marrow function: (1) Blood routine: hemoglobin value >= 90g/L, neutrophil count >= 2 x 10^9/L, platelet count >= 100 x 10^9/L; (2) Liver function: serum total bilirubin= 50ml/min; (4) Coagulation function: INR, APTT and PT are all = 28g/L; (6) Thyroid-stimulating hormone (TSH) and free thyroxine (fT4) are within the normal range of ± 10%; (7) There is no obvious abnormality in the electrocardiogram, and the myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that the simple laboratory abnormality does not have clinical significance, it is also allowed to enter the group); 6. Not receiving blood transfusion, blood products or blood cell growth factor such as granulocyte colony stimulating factor treatment within 2 weeks; 7. Sign an informed consent form before commencing study-specific screening procedures; 8. The expected survival period is more than 3 months; 9. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;If there is a risk of conception, all subjects (whether male or female) are required to use an annual failure rate of less than 1 throughout the treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy) % of contraception.
Exclusion criteria
Exclusion criteria: 1. Those with allergic diseases, severe drug allergy history, known to have previous allergy to monoclonal antibodies, any components of camrelizumab, or bevacizumab; 2. History of other malignancies with disease-free survival =103copies/ml after regular antiviral treatment); 7. Any of the following complications: gastrointestinal bleeding, perforation or gastrointestinal obstruction (including paralytic ileus); 8. Women who are breastfeeding; 9. Mental illness that hinders study compliance; 10. Definition of previous treatment (systemic, local) including any systemic anti-tumor therapy or local therapy for target lesions in the past; anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody in the past Antibodies or anti-CTLA-4 antibodies (or any other antibodies that act on T cell costimulation or checkpoint pathways); 11. Restrictions on immunomodulatory drugs and other anti-tumor traditional Chinese medicines: Received Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, and interleukin, except for local control of pleural effusion) within 28 weeks before the first administration systemic therapy with ); 12. Administer live attenuated vaccines, including the new crown vaccine, within 30 days of the first drug use or expected within the study period; 13. Subjects undergoing systemic treatment such as bronchodilators and unsatisfactory asthma control cannot be included (asthma has been completely relieved in childhood, and does not require any intervention in adulthood); 14. The subjects have received or plan to receive solid organ or blood system transplantation (except corneal transplantation) during the study period; 15. Participating in other clinical studies at the same time, currently participating in interventional clinical research treatment, or receiving other experimental drug or research device treatment within 4 weeks before the first dose; before the first dose, there is no toxicity caused by any intervention measures. and/or adequate recovery from complications (ie, <= grade 1 or at baseline, excluding fatigue or alopecia); 16. Patients with blood in stool or positive occult blood; 17. Other situations that the researc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete pathological response rate; | — |
Countries
China
Contacts
Public ContactJiang Tao
The Affiliated Hospital of Qingdao University
Outcome results
None listed