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To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR

ConditionLocally Advanced Rectal Cancer (LARC)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab 200mg Q3W 2 cycles

  • CAPOX (oxaliplatin/capecitabine)

    Drug

    CAPOX Q3W 2 cycles

  • Short-course radiotherapy

    Radiation

    Short-course radiotherapy 25Gy/5 doses, completed within one week

  • Intestinal bacteria transplantation

    Biological/Vaccine

    Intestinal bacteria transplantation Q3W 2 cycles

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response rate

Time frame
After surgery, an average of 1-2 weeks

Secondary outcomes

1

Objective response rate

Time frame
After the drug treatment is completed, an average of 1-2 weeks
2

Major Pathological Response

Time frame
After surgery, an average of 1-2 weeks
3

R0 resection rate

Time frame
After surgery, an average of 1-2 weeks
4

sphincter-preserving rate

Time frame
After surgery, an average of 1-2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: