Rectal Cancer
Conditions
Interventions
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age greater than 18 years and less than 75 years old; 2) physical fitness ECOG score 0-1; 3) Pathologically confirmed adenocarcinoma of the rectum; 4) Lower tumor margin = 12 cm from the anal verge (endoscopy) or = 8 cm from the anorectal ring (ARJ); 5) Initial MRI local staging of T3-4 or positive lymph nodes; and receiving radiotherapy combined with immunotherapy. 6) No evidence of distant metastasis; 7) No history of pelvic radiotherapy; 8) No history of surgery or chemotherapy for rectal cancer; 9) No concomitant systemic infection requiring antibiotic therapy; 10) no immune system disease 11) Blood count: ANC>1.5 cells/mm3, HGB>9.0 g/dL, PLT>100,000/mm3; 12) Blood biochemistry: total bilirubin =1.5xULN, AST =2.5xULN, ALT =2.5xULN; 13) Serum creatinine =1.5x upper limit of normal and endogenous creatinine clearance =50mL/min (Cockcroft-Gault formula); 14) Patients with well-controlled hypertension were allowed to enroll; 15) International Normalized Ratio (INR), activated partial thromboplastin time (aPTT) = 1.5 times upper limit of normal (only for patients not receiving anticoagulation; patients receiving anticoagulation should have anticoagulants in the therapeutically required range); 16) Normal or abnormal FT3, FT4, and TSH of no clinical significance; 17) Normal cardiac function, i.e., normal or abnormal without clinical significance on electrocardiogram and left ventricular ejection fraction (LVEF) greater than 50% on cardiac ultrasound; 18) The patient reads and signs the informed consent form for the study and agrees to participate in the study; 19) Patients voluntarily enroll in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. It is recommended that all patients provide tumor tissue specimens for pathology/immune microenvironment testing before enrollment; 20) Reproductively active males or females with the potential for pregnancy must use a highly effective method of contraception throughout the trial and continue to use contraception for 12 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1) Recurrent rectal cancer; 2) microsatellite instability (MSI) or mismatch repair gene deletion (dMMR) 3) Patient has had another malignancy within the past 5 years (other than properly treated basal cell carcinoma and squamous skin carcinoma); 4) the patient has had an atheroembolic disease in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc; 5) Received other types of antitumor or experimental treatments; 6) the patient is a pregnant or breastfeeding female; 7) the patient has other comorbidities or abnormal mental status that may affect the patient's participation in this study; 8) Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy and or VEGFR TKI therapy. major surgical procedure or have not recovered from the side effects of this procedure, live vaccination, immunotherapy within 4 weeks prior to the first dose of study drug, and radiotherapy within 2 weeks. 9) Known hypersensitivity to treatment-related drugs (capecitabine, oxaliplatin, PD-1) 10) Active lung disease (interstitial pneumonitis, pneumonia, obstructive lung disease, asthma) or history of active tuberculosis. 11) Have any uncontrolled clinical problems, including but not limited to: a Persistent or active (severe) infection; b poorly controlled hypertension (blood pressure persistently greater than 150/90 mmHg) on medication c poorly controlled diabetes; dHeart disease (class III/IV congestive heart failure or heart block as defined by the New York Heart Association); ePossession of or suspicion of autoimmune disease, or history of autoimmune disease or syndromes requiring systemic treatment with steroids/immunosuppressants, e.g., hypopituitarism, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism; 12) Other severe, acute or chronic medical conditions or abnormal laboratory tests that, in the judgment of the Investigator, may increase the risks associated with participation in the study or may interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response; | — |
Countries
China
Contacts
Public ContactWang Weihu
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute
Outcome results
None listed