Status:
UNKNOWN
Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT03801668
Start Date
March 8 2019
End Date
March 31 2023
Last Update
January 4 2022
Active Locations (1)
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1
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030