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NCT Number: NCT07738042

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

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)

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location contact

Zhansheng Jiang

CONTACT

[email protected]

008618526812877

Zhansheng Jiang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Intestinal bacteria transplantation Q3W 2 cycles

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

  5. Safety(Adverse reactions)

    Time frame: During the treatment period, up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Zhansheng Jiang

CONTACT

[email protected]

008618526812877

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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