Gastric Cancer
Conditions
Brief summary
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.
Interventions
DRUGNab-paclitaxel combined with oxaliplatin and S-1
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.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Jianjun Yang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | 2-year | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 7-month | 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. |
| Disease Control Rate (DCR) | 7-month | 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. |
| Overall survival (OS) | 2-year | It is defined as the time from the first doses durg to the time of death due to any reason. |
Countries
China
Outcome results
None listed