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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Albumin-bound Paclitaxel plus S-1; Drug: Oxaliplatin plus S-1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03801668

TJCC008

Details and patient eligibility

About

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.

Enrollment: 294 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of 18-75 years;
2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
3. At least one measurable lesion as defined by RECIST 1.1 criteria;
4. ECOG performance status of 0-1;
5. Estimated life expectancy of at least 3 months;
6. Left ventricular ejection fraction (LVEF) ≥ 50%;
7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
8. 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;
9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
10. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion criteria

1. 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;
2. HER-2 positive;
3. Patients with symptomatic brain metastases;
4. II-IV peripheral neuropathy [NCI-CTCAE 4.03];
5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
6. Patients with serious systemic infection or other diseases;
7. Allergic to the chemotherapy drugs or the materials in this study;
8. Patients with gastrointestinal bleeding that need clinical intervention;
9. Patients with digestive tract obstruction or oral nutrition difficulty;
10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
11. Have participated in other clinical trials within 28 days prior to the first dose of this study;
12. Contraindications to chemotherapy;
13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 2 patient groups

Nab-P/S-1

Experimental group

Description:

Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.

Treatment:

Drug: Albumin-bound Paclitaxel plus S-1

SOX

Active Comparator group

Description:

Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.

Treatment:

Drug: Oxaliplatin plus S-1