Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer

Study Overview
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Brief Summary
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This is a prospective, single-center, open, historically controlled real-world study. The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.

Official Title
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Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Nab-paclitaxel combined with oxaliplatin and S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric adenocarcinoma diagnosed by histology. Ambulatory cases, 18-75 years old ECOG performance status ≤ 1 Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) Patients able to tolerate abdominal surgery above grade 3 Has adequate organ function as defined by the following criteria: WBC> 4.0×10^9/L ANC> 1.5×10^9/L ANC ≥ 1.5×10^9/L HB ≥ 80 g/L PLT ≥ 100×10^9/L TBIL ≤ 1.5×ULN ALT and AST <2.5 × ULN, for patients with liver metastases, ALT and AST <5 × ULN BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min No history of other tumors Be willing and able to comply with the plan during the research period Has given written informed consent Life expectancy ≥ 6 months Exclusion Criteria: Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ HER-2+ and willing to receive Trastuzumab Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs Patients with other surgical contraindications, such as serious diseases that are difficult to control The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR > 1.5) Active HBV or HCV Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0 Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Nab-paclitaxel combined with oxaliplatin and S-1 | Drug: Nab-paclitaxel combined with oxaliplatin and S-1<br>* Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0 | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the rate of complete response (CR) or partial response (PR), as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. | 7-month | 
| Disease Control Rate (DCR) | The proportion of all subjects who assessed the best overall curative effect as CR, PR, and disease stable (SD) according to the RECIST 1.1 standard. | 7-month | 
| Overall survival (OS) | It is defined as the time from the first doses durg to the time of death due to any reason. | 2-year |