Rectal caner
Conditions
Interventions
Experimental group:Preoperative Short-course Radiotherapy followed by Chemotherapy and PD-L1 inhibitor
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years, any gender; 2. Staging by MRI or endoscopic ultrasound as stage II/III (cT3-T4N0 or cT2-4N, no distant metastasis, according to the 8th edition of the AJCC Cancer Staging Manual 2018, see Appendix 1. Rectal TNM staging); 3. Fiberoptic colonoscopy or rectal examination shows the lower margin of the lesion is = 90 g/L, White blood cells >= 3.5×10^9/L; Neutrophils >= 1.5×10^9/L, Platelets >= 100×10^9/L; Creatinine <=1.0×normal upper limit (UNL), Blood urea nitrogen (BUN) <=1.0×normal upper limit (UNL); Alanine aminotransferase (ALT) <=1.5×normal upper limit (UNL); Aspartate aminotransferase (AST) <=1.5×normal upper limit (UNL); Alkaline phosphatase (ALP) <=1.5×normal upper limit (UNL); Total bilirubin (TBIL) <=1.5×normal upper limit (UNL); Urine protein (-); Normal coagulation time. 7. No history of allergy to 5-Fu drugs, no history of allergy to platinum drugs; 8. Patients with primary rectal cancer should not have undergone surgery (except for palliative colostomy), chemotherapy, or other anti-tumor treatments from diagnosis to enrollment; 9. The planned radiation therapy site should not have received radiation previously; 10. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. previous treatment with anti-PD-1/L1 and anti-CTLA-4 immunologic drugs or other immunologic experimental drugs; 2. patients with severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc; 3. symptomatic interstitial lung disease or active infectious/non-infectious pneumonia; 4. patient has risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) tract (GI) obstruction, abdominal cancer, or other known risk factors for bowel perforation; 5. history of other malignancies, excluding curable non-melanotic skin cancer and carcinoma in situ of the cervix; 6. patients with active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia; 7. physical examination or clinical laboratory findings that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable medical conditions; 8. nursing or pregnant females; 9. congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation, or allogeneic stem cell transplantation; 10. known active hepatitis B virus (HBV) hepatitis (HBV-DNA >= 2000 U/mL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection; 11. the patient has received a tumor vaccine or has received another vaccine within 4 weeks prior to starting treatment; (Note: Since injectable seasonal influenza vaccine is mostly inactivated and therefore permitted, whereas intranasal preparations are usually live attenuated vaccines and therefore not permitted); 12. patients on other immunologic agents, chemotherapeutic agents, other agents under clinical investigation, and long-term cortisol therapy will not be enrolled; 13. Patients with mental illness, substance abuse, social problems that affect compliance will not be enrolled upon review by the physician; 14. patients who are allergic to or contraindicated for therapeutic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;Local recurrence rate;R0 Resection Rate;Distant metastasis rate;The rate of 3-years overall survival;Clinical complete response (cCR); | — |
Countries
China
Contacts
Public ContactXiushen Wang
Henan Cancer Hospital
Outcome results
None listed