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Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06356597
Enrollment
33
Registered
2024-04-10
Start date
2024-04-19
Completion date
2027-12-12
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical.

Interventions

DRUGTislelizumab with Fruquintinib, Metronidazole

Metronidazole tablets: One administration cycle is every 6 weeks, and metronidazole tablets are given orally on the 1st to 7th day of each cycle. The medication method is two tablets three times one day. Teralizumab: Every 3 weeks is a dosing cycle, with 200mg of Teralizumab administered intravenously on the first day of each cycle.

Sponsors

Jing-yuan Fang, MD, Ph. D
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 CT value \< 35 in fecal samples, and Fn is confirmed positive by agarose gel electrophoresis or Sanger sequencing 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.

Design outcomes

Primary

MeasureTime frameDescription
PFSThe time from when the patient first receives immunotherapy and Metronidazole to the earliest evidence of disease progression,or date of death from any cause, whichever came first, assessed up to 100 months.Progression-Free-Survival

Secondary

MeasureTime frameDescription
ORRThe proportion of patients whose tumor volume has shrunk to a predetermined value (usually 30%) and can maintain the minimum time limit requirement is the sum of complete remissionand partial remission.Objective Response Rate
OSThe time from when the patient first receives immunotherapy and Metronidazole to death, assessed up to 100 months.Overall Survival
DCRThe proportion of patients whose tumors have achieved remission (PR+CR) and disease stability (SD, tumor shrinkage has not reached 30% but has not progressed) after treatment.Disease Control Rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026