Clinical trial · Interventional
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
NCT07738042CI-TRIAL-00119873not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer (LARC) | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPOX (oxaliplatin/capecitabine) | Drug | CAPOX Regimen | ALIAS |
| Intestinal bacteria transplantation | Biological | — | UNRESOLVED |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- interventionNames
- Drug: Sintilimab
- Drug: CAPOX (oxaliplatin/capecitabine)
- Radiation: Short-course radiotherapy
- Biological: Intestinal bacteria transplantation
Primary outcomes (1)
- measure
- Pathological Complete Response rate
- timeFrame
- After surgery, an average of 1-2 weeks
Secondary outcomes (5)
- measure
- Objective response rate
- timeFrame
- After the drug treatment is completed, an average of 1-2 weeks
- measure
- Major Pathological Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.