Clinical trial · Interventional
Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer
Fusobacterium Nucleatum Eradication in Postoperative Stage II/III Colorectal Cancer(FINER-PACE)by Oral Metronidazole: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
- 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)
Fusobacterium nucleatum (Fusobacterium nucleatum, Fn) has been identified as an independent risk factor for recurrence of colorectal cancer. In this study, oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage II | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metronidazole Oral Tablet | Drug | — | UNRESOLVED |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metronidazole
- description
- supplement of metronidazole 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6(6 treatments totally),and every 6 weeks for CapeOX (4 treatments totally).
- interventionNames
- Drug: Metronidazole Oral Tablet
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- supplement of identical-appearing placebo 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6 (6 treatments totally),and every 6 weeks for CapeOX 4 treatments totally).
- interventionNames
- Drug: Placebo oral tablet
Primary outcomes (1)
- measure
- Disease Free Survival, DFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals aged 18-75 years * Individuals firstly confirmed by surgery pathology as colorectal cancer (AJCC cancer staging II - III), who need mFOLFOX6 or CapeOX postoperative chemotherapy * Individuals with Fn - deltaCT value in colon tissue samples detected by qPCR ≥-12 before receiving chemotherapy * Individuals who could tolerate chemotherapy drugs: ECOG (Eastern Cooperative Oncology Group) score ≤2 points, WBC(White Blood Cell) ≥4.0×10\^9/L, Hb （Hemoglobin） ≥80g/L, PLT （Platelet） ≥80×10\^9/L, ALT （Alanine Aminotransferase）\< 2ULN （Upper Limmit of Normal）, Scr （Creatinine）\< 1.5ULN * Individuals who participate this study and sign the informed consent form willingly. Exclusion Criteria: * Individuals with colorectal adenoma or non-colorectal cancer, such as inflammatory bowel disease * Individuals with a history of familial adenomatous polyposis (FAP) * Individuals with severe heart, lung, brain, kidney, gastrointestinal or systemic diseases * Individuals who used antibiotics for more than 5 days in 1 month prior to chemotherapy * Individuals with stage I or IV colorectal cancer, or with stage II colorectal cancer who do not need postoperative chemotherapy * Individuals with contraindications for metronidazole * Individuals who unwilling to participate this study，or unwilling to sign the informed consent form * Individuals with any conditions that the researchers considered inappropriate for inclusion
References
Publications (0)
Data not yet available