rectal cancer
Conditions
Interventions
B group:CAPOX: Oxaliplatin 130mg/m2, ivgtt, d1, q3w
Cap 1000mg/m2 po, bid, d1-14, q3w, 2 cycles
A group:Tislelizumab 200 mg, ivgtt, d1, q3w+ CAPOX Oxaliplatin:130mg/m2, ivgtt, d1, q3w
Sponsors
Qingdao Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender is not limited; 2. Stage II/ III under MRI or endoscopic ultrasound (cT3-T4N0 or cT2-4N+, no distant metastasis, according to the 2018 AJCC Cancer Staging Handbook, 8th edition); 3. Fibrocolonoscopy or examination, the lower limit of the lesion is = 80 points or ECOG score of 0-1; 6. Meet the following laboratory diagnostic indicators: hemoglobin=100g/L, leukocyte >= 3.5×10^9/L, neutrophils>= 1.5×10^9/L, platelet >= 100×10^9/L, creatinine<= 1.0× upper limit of normal (UNL), urea nitrogen (BUN) <= 1.0×upper limit of normal (UNL), alanine aminotransferase (ALT) <= 1.5× upper limit of normal (UNL), aspartate aminotransferase (AST) <= 1.5× upper limit of normal (UNL), Alkaline phosphatase (ALP) <= 1.5× upper limit of normal (UNL), Total bilirubin (TBIL) <= 1.5× upper limit of normal (UNL), urine protein (-), Clotting time is normal. 7. No history of allergy to class 5-Fu drugs, no history of allergy to platinum drugs; 8. Primary rectal cancer patients are required to have not undergone surgery (except palliative fistula), chemotherapy or other anti-tumor treatment from diagnosis to enrollment; 9. The site to be radiotherapy has not received radiation before; 10. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received anti-PD-1/ L1 and anti-CTLA-4 immune drugs or other immune experimental drug treatment in the past; 2. Patients have severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener granulomatosis), etc. 3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia; 4. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation; 5. History of other malignant tumors, excluding curable non-melanotic skin cancer and carcinoma in situ of the cervix; 6. The patient has active infection, heart failure, myocardial infarction within 6 months, unstable angina pectoris or unstable arrhythmia; 7. Physical examination or clinical trial findings that the investigator believes may interfere with the results or increase the risk of treatment complications for the patient, or other uncontrollable diseases; 8. Nursing or pregnant women; 9. Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation; 10. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis infection; 11. The patient has been vaccinated against tumors, or has received other vaccines within 4 weeks before starting treatment (Note: Because the seasonal influenza vaccine for injection is mostly an inactivated vaccine, it is allowed, while the intranasal preparation is usually a live attenuated vaccine and therefore is not allowed); 12. Patients treated with other immunological preparations, chemotherapy drugs, drugs in other clinical studies, and cortisol treatment at the same time will not be enrolled; 13. Patients with mental illness, substance abuse, and social problems that affect adherence will not be enrolled after medical review; 14. Those who are allergic or contraindicated to treatment drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year DFS rate, and 3-year overall survival rate;Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results;Expression of immune markers and distribution of immune cells in tumor tissue and blood; | — |
Countries
China
Contacts
Public ContactXiaotao Zhang
Qingdao Central Hospital
Outcome results
None listed