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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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.
Shanghai First People's Hospital
Shanghai, China
Shanghai Ninth People's Hospital
Shanghai, China
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.
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.
OS
Overall Survival
Time frame: The time from when the patient first receives immunotherapy and Metronidazole to death, assessed up to 100 months.
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.
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