Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Albumin-bound Paclitaxel plus S-1
* Drug: Oxaliplatin plus S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-75 years; Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma; At least one measurable lesion as defined by RECIST 1.1 criteria; ECOG performance status of 0-1; Estimated life expectancy of at least 3 months; Left ventricular ejection fraction (LVEF) ≥ 50%; Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L; 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; Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study; Able and willing to comply with the study plans in this protocol and sign the informed consent; Exclusion Criteria: 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; HER-2 positive; Patients with symptomatic brain metastases; II-IV peripheral neuropathy [NCI-CTCAE 4.03]; Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive; Patients with serious systemic infection or other diseases; Allergic to the chemotherapy drugs or the materials in this study; Patients with gastrointestinal bleeding that need clinical intervention; Patients with digestive tract obstruction or oral nutrition difficulty; Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer; Have participated in other clinical trials within 28 days prior to the first dose of this study; Contraindications to chemotherapy; Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-P/S-1<br>Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1. | Drug: Albumin-bound Paclitaxel plus S-1<br>* Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.<br>|
| Active Comparator: SOX<br>Patients in this arm receive chemotherapy with Oxaliplatin plus S-1. | Drug: Oxaliplatin plus S-1<br>* Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | PFS is defined as time from the start of treatment to progression of disease or death. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | up to 3 years | 
| Overall survival (OS) | Overall survival is defined as time from the start of treatment until death due to any reason. | up to 3 years | 
| Safety as measured by number and grade of adverse events | Summary adverse events according to NCI-CTCAE 4.03 | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Albumin-bound Paclitaxel