Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment group Nab-paclitaxel combined with oxaliplatin and S-1 |
Drug: Nab-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.
|
Outcome Measures
Primary Outcome Measures
- AE [2-year]
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Gastric adenocarcinoma diagnosed by histology.
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Ambulatory cases, 18-75 years old
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ECOG performance status ≤ 1
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Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
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Patients able to tolerate abdominal surgery above grade 3
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Has adequate organ function as defined by the following criteria:
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WBC> 4.0×10^9/L
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ANC> 1.5×10^9/L
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ANC ≥ 1.5×10^9/L
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HB ≥ 80 g/L
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PLT ≥ 100×10^9/L
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TBIL ≤ 1.5×ULN
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ALT and AST <2.5 × ULN, for patients with liver metastases, ALT and AST <5 × ULN
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BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min
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No history of other tumors
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Be willing and able to comply with the plan during the research period
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Has given written informed consent
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Life expectancy ≥ 6 months
Exclusion Criteria:
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Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
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HER-2+ and willing to receive Trastuzumab
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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
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Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
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Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
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Patients with other surgical contraindications, such as serious diseases that are difficult to control
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The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR > 1.5)
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Active HBV or HCV
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Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0
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Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of the Air Force Medical University | Xi'an | China |
Sponsors and Collaborators
- Jianjun Yang
- CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-KIL-GC-006