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OncoMatch/Clinical Trials/NCT06728072

Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Is NCT06728072 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin for colorectal cancer.

Phase 2RecruitingVirginia Commonwealth UniversityNCT06728072Data as of May 2026

Treatment: Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirinThis is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: antibiotics

Exception: prophylactic antibiotics at time of surgery allowed

Full course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed

Lab requirements

Blood counts

ANC ≥1,500 cells/μL; Platelet count ≥100,000 cells/μL; Hemoglobin ≥8 g/dL (transfusion/intervention allowed to achieve threshold)

Kidney function

Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation

Liver function

AST and ALT ≤2.5 × ULN; if liver metastases: AST and ALT ≤5 × ULN

Cardiac function

Corrected QT interval (QTc) ≤480 on baseline ECG

ANC ≥1,500 cells/μL; Platelet count ≥100,000 cells/μL; Hemoglobin ≥8 g/dL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g/dL is acceptable. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN; Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation; Corrected QT interval (QTc) >480 on baseline ECG [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Virginia Commonwealth University · Richmond, Virginia

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