Locally advanced rectal cancer
Conditions
Interventions
Test group:Short-course radiotherapy+AK104 injection+Oxaliplatin+Carbazitabine+TME surgery
Sponsors
Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 15m from the margin; 4. Rectal adenocarcinoma confirmed or reviewed by pathology; 5. Karl Fischer score>= 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 |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response rate (MPR);Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results;3-year DFS rate, and 3-year overall survival rate; | — |
Countries
China
Contacts
Public ContactJing Jin
Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed