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Active, not recruitingNCT06356597Updated Feb 24, 2026

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

A Phase 2 interventional study of Tislelizumab with Fruquintinib, Metronidazole in Colorectal Cancer, sponsored by Jing-yuan Fang, MD, Ph. D. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Jing-yuan Fang, MD, Ph. D · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 33 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Jing-yuan Fang, MD, Ph. D is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Tislelizumab with Fruquintinib, Metronidazole

    Drug: Tislelizumab with Fruquintinib, Metronidazole

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.

06

What researchers measure

Primary outcomes

  1. PFS

    Progression-Free-Survival

    Time frame: The 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.

Secondary outcomes

  1. ORR

    Objective Response Rate

    Time frame: The 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.

  2. OS

    Overall Survival

    Time frame: The time from when the patient first receives immunotherapy and Metronidazole to death, assessed up to 100 months.

  3. DCR

    Disease Control Rate

    Time frame: The 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.

07

Study locations

2 sites
  • Shanghai First People's Hospital
    Shanghai, China
  • Shanghai Ninth People's Hospital
    Shanghai, China
08

References and documents

Publications

  • Jiang SS, Xie YL, Xiao XY, Kang ZR, Lin XL, Zhang L, Li CS, Qian Y, Xu PP, Leng XX, Wang LW, Tu SP, Zhong M, Zhao G, Chen JX, Wang Z, Liu Q, Hong J, Chen HY, Chen YX, Fang JY. Fusobacterium nucleatum-derived succinic acid induces tumor resistance to immunotherapy in colorectal cancer. Cell Host Microbe. 2023 May 10;31(5):781-797.e9. doi: 10.1016/j.chom.2023.04.010. Epub 2023 May 1. PubMed 37130518 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06356597
Lead sponsor
Jing-yuan Fang, MD, Ph. D
Responsible party
Jing-yuan Fang, MD, Ph. D (Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Apr 10, 2024
Start date
Apr 19, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 12, 2027 (estimated)
Last update
Feb 24, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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