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NCT06793137
Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Phase 2 trial testing Metronidazole in Rectal Cancer, Adenocarcinoma in 100 participants. Currently enrolling.
31 October 2025
Quick facts
| Lead sponsor | AC Camargo Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 22 July 2024 |
| Primary completion | 31 October 2025 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Metronidazole (METRONIDAZOLE) — full drug profile →
Conditions studied
- Rectal Cancer, Adenocarcinoma — all drugs for Rectal Cancer, Adenocarcinoma →
Sponsor
AC Camargo Cancer Center — full company profile →
Who can join
18 and older, any sex, with Rectal Cancer, Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Colorectal cancer is the second most common malignancy worldwide and one-third of these tumors are located in the rectum. The treatment may involve up to three modalities: radiotherapy, chemotherapy, and surgery. For several years, thanks mainly to Brazilian researchers, subgroups of patients have been selected for non-surgical treatment when chemoradiotherapy induces a complete clinical response. These treatment regimens have reached a plateau leading researchers to seek strategies that can increase response rates. Intestinal microbiota studies have shown that an overpopulation of certain anaerobic bacteria is generally associated with poorer treatment response. No study has attempted to intervene in the gut microbiota to increase the complete response rate in rectal cancer. The proposal of the investigators aims to modulate the intestinal microbiota through a phase 2 clinical trial, with the use of metronidazole as the intervention .
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Microbiota in cancer: current understandings and future perspectives.
Yao Y, Zhu Y, Chen K, Chen J, et al · · 2026 · cited 2× · PMID 41629271 · DOI 10.1038/s41392-025-02335-3 -
Intratumoral microbiota in cancer: molecular mechanism and therapeutic strategies.
Yu Y, Guo Z, Luo Z, Dian Y, et al · · 2026 · PMID 42171956 · DOI 10.1186/s43556-026-00473-w -
Gut microbiota drives cancer evolution and therapy resistance.
Min S, Zhang Y, Zhang H, Liu Q. · · 2026 · PMID 41527087 · DOI 10.1186/s12943-025-02564-8
Verify or expand the search:
- PubMed search for NCT06793137
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metronidazole
Trials testing the same drug.
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- NCT07492134 — APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) · Phase 2 · not yet recruiting
- NCT06627270 — Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer · Phase 2 · recruiting
- NCT06616597 — Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Meta · Phase 2 · recruiting
- NCT06798415 — Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis · Phase 2 · recruiting
Other recruiting trials for Rectal Cancer, Adenocarcinoma
Currently open trials in the same condition.
- NCT07458529 — Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT07474103 — SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC · NA · recruiting
- NCT07407465 — Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal · Phase 2 · recruiting
Other AC Camargo Cancer Center trials
Trials by the same sponsor.
- NCT07285356 — Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy · NA · recruiting
- NCT07268846 — Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery · NA · recruiting
- NCT06472388 — Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors · Phase 2 · recruiting
- NCT06207487 — Evaluation of Herpes Zoster Characteristics and Costs in Cancer Population. · unknown
- NCT06215027 — The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06793137 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AC Camargo Cancer Center
- Last refreshed: 29 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06793137.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing