Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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)
Eligibility criteria
Qualifiers
ECOG PS 0-1
The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible
RAS/BRAF wild type, pMMR/MSS status
Patients of childbearing age need to take effective contraceptive measures.
Disqualifiers
dMMR/MSI-H type
Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
Active autoimmune diseases, inflammatory bowel disease;
Active infection, immune deficiency, severe liver and kidney dysfunction;
Trial design
Treatments tested in this trial
- Sintilimab
- CAPOX (oxaliplatin/capecitabine)
- Short-course radiotherapy
- Intestinal bacteria transplantation
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov