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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356597
• Other study ID #: KY2024-004-A
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: December 12, 2027

Study information

• Verified date: April 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: shanshan Jiang
• Phone: +8613651656130
• Email: shanshanjss[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 12, 2027
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Tislelizumab 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.

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jing-yuan Fang, MD, Ph. D

Country where clinical trial is conducted

China, 

References & 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 immun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		3 months and 6 months