A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab
To observe the efficacy, safety, postoperative pathological remission rate and survival benefit of patients with HER-2 positive locally advanced adenocarcinoma of stomach and gastroesophageal junction treated with camrelizumab+SOX combined with trastuzumab or not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
camrelizumab was administered intravenously at a fixed dose of 200 mg, on the first day, once every 3 weeks, with a cycle of 3 weeks. Infusion for 30 min each time (no less than 20 min and no more than 60min); SOX: Oxaliplatin: 130 mg/m2, administered intravenously, on the first day, once every three weeks, and every three weeks is a cycle; S-1: according to BSA (\< \<1.25 40 mg;; 1.25-1.5 50 mg; \> \>1.5 60 mg), oral administration, d1-d14 twice a day, 3 weeks as a cycle; Trastuzumab was administered intravenously, with an initial loading dose of 8 mg/kg and a subsequent dose of 6 mg/kg, with a cycle of 3 weeks.
Henan Tumor Hospital
Henan, China
RECRUITINGPathological complete response rate(pCR)
Refers to the absence of tumor cell residue in the primary tumor.
Time frame: up to 2 years
Disease-free survival
Defined as postoperative disease-free subjects, starting from the time of postoperative baseline imaging evaluation to the time of disease recurrence or death.
Time frame: up to 2 years
Overall survival
defined as the time from the first medication to the death of a subject from any cause after enrollment. For the subjects who survived at the last contact, their total survival will be deleted on the last contact day.
Time frame: up to 2 years
Major pathological response rate
The survival tumor cells in the resected specimen were ≤10%.
Time frame: up to 2 years
R0 resection rate
There was no macroscopic tumor at the surgical margin, and the tumor cells at the surgical margin were negative within 1mm under microscope.
Time frame: up to 2 years
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