Combining Tislelizumab, Fruquintinib, and Metronidazole for Advanced Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai First People's Hospital
  Shanghai, China Recruiting
• Shanghai Ninth People's Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: shanshan Jiang
• Email: shanshanjss@163.com
• Phone: +8613651656130

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• DSP107 plus atezolizumab versus fruquintinib for advanced colorectal cancer

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• Fruquintinib plus FOLFIRI for second-line metastatic colorectal cancer

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• Fruquintinib plus tislelizumab versus trifluridine/tipiracil plus bevacizumab for MSS/pMMR metastatic colorectal cancer without active liver metastases

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  Recruiting at 15 sites Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Linz and 22 other locations · NCT06856837

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.