To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
203
Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
Oxaliplatin for Injection 135mg/m2 /per day,ivgtt,in day1. Given once every 3 weeks.
S-1 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
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Objective response rate
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
Time frame: 4 months
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy.
Time frame: 4 months
Disease control rate
Time frame: 4 months
1-year and 3-year OS/DFS
Time frame: 1 and 3 years
adverse event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: 3 years
overall postoperative morbidity rates
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time frame: 30 days
30 days mortality rates
Defined as the event observed within 30 days after surgery.
Time frame: 30 days
Duration of postoperative hospital stay
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Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.
nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8.
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 30 days
The prediction performance of Exosome contents (including proteins, nucleic acids)
Exosomes were isolated using a Backman Optima XPN-100 instrument. The exosomes morphology was characterized using a HT7700 transmission electron microscope (Hitachi, Co. Ltd., Japan). Fluorescent spectra were recorded using a F96 Pro fluorospectrophotometer (Shanghai Lengguang Technology). The concentration and size distribution of the exosomes were quantified using nanoparticle tracking analysis (NanoSight NS 300, Malvern Instrument). The obtained results were subjected to biostatistical analysis, such as heat map generation, ROC curve establishment, and confusion matrix.
Time frame: 3 years