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

NCT07738042 | Not Yet Recruiting

• 1 other identifier: LARC-BCAPOX
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)

Conditions

Locally Advanced Rectal Cancer (LARC)

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response rate

  After surgery, an average of 1-2 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: Sintilimab; Drug: CAPOX (oxaliplatin/capecitabine); Radiation: Short-course radiotherapy; Biological: Intestinal bacteria transplantation

Interventions

Sintilimab DRUG

Sintilimab 200mg Q3W 2 cycles

Treatment group

CAPOX (oxaliplatin/capecitabine) DRUG

CAPOX Q3W 2 cycles

Treatment group

Short-course radiotherapy RADIATION

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

Treatment group

Intestinal bacteria transplantation BIOLOGICAL

Intestinal bacteria transplantation Q3W 2 cycles

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Voluntarily sign the informed consent form

You may not qualify if:

• 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;
• Severe intestinal obstruction, perforation or requiring emergency surgery;
• Pregnant or lactating women;
• Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.);
• Other circumstances where participation in clinical trials is not suitable

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

MeSH Terms

Interventions

sintilimab; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zhansheng Jiang

CONTACT

008618526812877; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 30, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)