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Trial Title:
Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial
NCT ID:
NCT06356597
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Metronidazole
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab with Fruquintinib, Metronidazole
Description:
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.
Arm group label:
Tislelizumab with Fruquintinib, Metronidazole
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai First People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qi Li
Facility:
Name:
Shanghai Ninth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanjie Zhang
Start date:
April 1, 2024
Completion date:
December 12, 2027
Lead sponsor:
Agency:
Jing-yuan Fang, MD, Ph. D
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356597
