Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
Study Details
Study Description
Brief Summary
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Nab-P/S-1 Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1. |
Drug: Albumin-bound Paclitaxel plus S-1
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
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Active Comparator: SOX Patients in this arm receive chemotherapy with Oxaliplatin plus S-1. |
Drug: Oxaliplatin plus S-1
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
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Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [up to 3 years]
PFS is defined as time from the start of treatment to progression of disease or death.
Secondary Outcome Measures
- Overall Response Rate (ORR) [up to 3 years]
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
- Overall survival (OS) [up to 3 years]
Overall survival is defined as time from the start of treatment until death due to any reason.
- Safety as measured by number and grade of adverse events [up to 3 years]
Summary adverse events according to NCI-CTCAE 4.03
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age of 18-75 years;
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Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
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At least one measurable lesion as defined by RECIST 1.1 criteria;
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ECOG performance status of 0-1;
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Estimated life expectancy of at least 3 months;
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Left ventricular ejection fraction (LVEF) ≥ 50%;
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Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
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Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases,total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
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Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
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Able and willing to comply with the study plans in this protocol and sign the informed consent;
Exclusion Criteria:
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Have received chemotherapy before;patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
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HER-2 positive;
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Patients with symptomatic brain metastases;
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II-IV peripheral neuropathy [NCI-CTCAE 4.03];
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Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
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Patients with serious systemic infection or other diseases;
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Allergic to the chemotherapy drugs or the materials in this study;
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Patients with gastrointestinal bleeding that need clinical intervention;
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Patients with digestive tract obstruction or oral nutrition difficulty;
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Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
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Have participated in other clinical trials within 28 days prior to the first dose of this study;
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Contraindications to chemotherapy;
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Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Huazhong University of Science and Technology
- CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
- Study Chair: Xianglin Yuan, MD,PhD, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJCC008