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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

Criteria

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.