Locally Advanced Rectal Cancer (LARC)
Conditions
Brief summary
To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)
Interventions
DRUGSintilimab
Sintilimab 200mg Q3W 2 cycles
CAPOX Q3W 2 cycles
RADIATIONShort-course radiotherapy
Short-course radiotherapy 25Gy/5 doses, completed within one week
BIOLOGICALIntestinal bacteria transplantation
Intestinal bacteria transplantation Q3W 2 cycles
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ECOG PS 0-1 2. The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible 3. RAS/BRAF wild type, pMMR/MSS status 4. Patients of childbearing age need to take effective contraceptive measures. 5. Voluntarily sign the informed consent form
Exclusion criteria
1. dMMR/MSI-H type 2. Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy); 3. Active autoimmune diseases, inflammatory bowel disease; 4. Active infection, immune deficiency, severe liver and kidney dysfunction; 5. Severe intestinal obstruction, perforation or requiring emergency surgery; 6. Pregnant or lactating women; 7. Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.); 8. Other circumstances where participation in clinical trials is not suitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response rate | After surgery, an average of 1-2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | After the drug treatment is completed, an average of 1-2 weeks |
| Major Pathological Response | After surgery, an average of 1-2 weeks |
| R0 resection rate | After surgery, an average of 1-2 weeks |
| sphincter-preserving rate | After surgery, an average of 1-2 weeks |
| Safety（Adverse reactions） | During the treatment period, up to 3 months |
Countries
China
Contacts
CONTACTZhansheng Jiang
Outcome results
None listed