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

NCT06356597 | Active Not Recruiting Phase 2

• 1 other identifier: KY2024-004-A
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free-Survival

  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 (3)

• ORR

  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.

• OS

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

• DCR

  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.

Study Arms (1)

Tislelizumab with Fruquintinib, Metronidazole

EXPERIMENTAL

Drug: Tislelizumab with Fruquintinib, Metronidazole

Interventions

Tislelizumab with Fruquintinib, Metronidazole DRUG

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.

Tislelizumab with Fruquintinib, Metronidazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jing-yuan Fang, MD, Ph. D: lead

Study Sites (2)

Shanghai First People's Hospital

Shanghai, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 37130518 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab; HMPL-013; Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CN (2)