Patients with locally advanced (T3-4/N+) pMMR/MMS type middle and low rectal cancer (the lower edge of the magnetic resonance tumor is within 10 cm from the anus)
Conditions
Interventions
Trial group (short-course radiotherapy + chemotherapy and immunotherapy + FMT group):Oral fecal microbiota transplantation (FMT) capsules: one unit contains 1×10^13 colony-forming units, with one unit
Control group (short-course radiotherapy + chemotherapy and immunotherapy ):Without FMT, the other treatments were identical to those in the experimental group: short-course radiotherapy (25 Gy/5 frac
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Colonoscopy biopsy confirmed rectal adenocarcinoma; 2. First-time treatment, no previous anti-tumor treatment or immunotherapy for rectal cancer; 3. The clinical stage of pelvic magnetic resonance imaging (plain scan + contrast + DWI) is T4 or T3, and/or the short diameter of pelvic lymph nodes >=7 mm (consultation record of senior professional title in the Department of Imaging); 4. Pelvic magnetic resonance imaging (plain scan + contrast + DWI): the distance between the lower edge of the tumor and the dentate line =18 years old, 10 years; 9. PS <=2; 10. Patients and their families can understand and are willing to participate in this study and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Severe other diseases, such as severe mental disorders, heart disease, uncontrollable infections, etc., consider being unable to tolerate surgery in the future; 3.Immunodeficiency disease or long-term use of immunosuppressants; 4.Baseline blood and biochemical indicators do not meet the standards for radiotherapy and chemotherapy:neutrophils>=2.5×10^9 /L,Hb>=80g/L, PLT>=100×10^9 /L,ALT/AST<=2.5 ULN,Cr<=1.5 ULN;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CR), including clinical complete response rate (cCR) and pathological complete response rate (pCR) after surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Grade 3-4 Acute Adverse Reactions;Surgical complication rate;3-year disease-free survival rate (DFS);3-year local recurrence-free survival rate (LRFS);3-year overall survival rate (OS); | — |
Countries
China
Contacts
Public ContactSong Yongchun
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed