To investigate the clinical efficacy and safety of envollizumab combined with fruquintinib and SOX versus SOX in conversion therapy for patients with Her-2 negative, unresectable locally advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Envolizumab 300mg, D1, ih, Q3W 4-6cycles
Fruquinitinib 3mg/d, QD, PO, D1-D14, Q3W 4-6cycles
Oxaliplatin 130 mg/m2, ivgtt 0-2h, D1, Q3W 4-6cycles
Surgical conversion rate
Defined as the proportion of patients who have undergone surgical resection after multidisciplinary assessment after completing 4-6 cycles of conversion therapy
Time frame: 2-3 months
Pathological complete response (pCR)
Measured as the proportion of participants with a pathological complete response at the time of definitive surgery.
Time frame: 4 months
Median disease free survival (DFS) time
The time from opreation to the time when only 50% of the individuals had no relapse or tumor progression
Time frame: 3 years
1-year DFS rate
Time frame: 1 year
3-year DFS rate
Time frame: 3 years
Objective response rate (ORR)
Defined as the percentage of the participants in the analysis population who had a confirmed patial response and complete reponse according to RECIST 1.1 based on investigator assessment
Time frame: 4 months
Major pathological response rate (MPR)
The proportion of participants with a major pathological response (mPR) at the time of definitive surgery.
Time frame: 4 months
R0 resection rate
Defined as no residue under the microscope after resection
Time frame: 2-3 month
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Tegafur was calculated according to body surface area , P.O., bid, d1-d14#And the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time Q3W 4-6cycles
Median survival time
The time from enrollment to the time when only 50% of the individuals alive
Time frame: 3 years
Adverse event (AEs)
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.
Time frame: 2 years
Quality of life (QOL)
The quality of life of patients during treatment is eveluated by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3.0)
Time frame: 2 years