Combining Tislelizumab, Fruquintinib, and Metronidazole for Advanced Colorectal Cancer

Division of Gastroenterology and Hepatology,Renji Hospital, School of Medicine, Shanghai Jiao Tong University

This study is testing a new combination treatment of Tislelizumab, Fruquintinib, and Metronidazole to see if it helps people with advanced colorectal cancer that hasn't responded to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: tirelizumab, immunotherapy, Tislelizumab, Fruquintinib
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT06356597 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving Tislelizumab, Fruquintinib, and Metronidazole in patients with advanced colorectal cancer that is mismatch repair-proficient or microsatellite stable. The study focuses on patients with high levels of Fusobacterium nucleatum and aims to provide a new treatment option for those who have already undergone standard therapies. It is a single-arm Phase II trial conducted across multiple centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage IV colorectal cancer that is MSS or MSI-L and have progressed after prior treatments.

Not a fit: Patients with colorectal cancer that is mismatch repair-deficient or those who have not progressed after standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with targeted therapies in colorectal cancer have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. No gender limit, age ≥ 18 years old and ≤ 80 years old;
2. Colorectal cancer (AJCC stage IV) diagnosed by histological or cytological biopsy as metastatic or unresectable, with immunohistochemical or genetic testing indicating MSS or MSH-L type;
3. Treatment requires third line or above, has previously received standard first and second line treatment, and the disease has progressed after treatment;
4. Before accepting tirelizumab, qPCR should be used to detect the Fn deltaCT value ≥ -22.24 in fecal samples;
5. ECOG score: 0-1 points;
6. Baseline blood routine and biochemical indicators meet the following criteria (no blood transfusion or use of colony stimulating factors 2 weeks prior to screening) Blood routine: hemoglobin ≥ 90g/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L Liver function: ALT and AST ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 x ULN (if there is liver metastasis, ALT and AST ≤ 5 x ULN, serum total bilirubin ≤ 3 x ULN), serum albumin ≥ 30g/L Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance rate ≥ 50 mL/min (calculated according to Cockcroft Gault formula).
7. Those who voluntarily participate in the trial and sign an informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Chronic intestinal diseases (such as Crohn's disease, ulcerative colitis, etc.), infectious intestinal diseases during the screening period, and intestinal obstruction during the screening period;
3. Subjects with poor control of hypertension (systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>100 mmHg) and a history of hypertensive crisis or hypertensive brain disease;
4. Severe liver and kidney function or heart dysfunction;
5. Patients who use antibiotics for more than 5 days within one month prior to immunotherapy;
6. Patients with known brain or meningeal metastases, regardless of whether they have received treatment, are not eligible for inclusion in this trial.
7. Individuals with contraindications to the use of metronidazole medication;
8. Those who are unwilling to participate in the trial or sign informed consent forms;
9. The researchers believe that there are any situations that are not suitable for selection.

Where this trial is running

Shanghai and 1 other locations

• Shanghai First People's Hospital — Shanghai, China (Recruiting)
• Shanghai Ninth People's Hospital — Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: shanshan Jiang

Conditions Colorectal Cancer