Nab-paclitaxel Combined With S-1 as Adjuvant Chemotherapy for Stage Ⅲ Gastric Cancer

  • End date
    Oct 31, 2024
  • participants needed
  • sponsor
    Zhejiang Cancer Hospital
Updated on 1 March 2022
platelet count
gastric adenocarcinoma
neutrophil count
cancer chemotherapy
adjuvant chemotherapy
xelox regimen


This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage gastric cancer as adjuvant setting


This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Condition Stomach Cancer
Treatment Capecitabine, Oxaliplatin, nab paclitaxel, Tegafur
Clinical Study IdentifierNCT04135781
SponsorZhejiang Cancer Hospital
Last Modified on1 March 2022


Yes No Not Sure

Inclusion Criteria

Age of 18-75 years
Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach
Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline
Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved
Ability to perform chemotherapy within 7 days of enrollment in the randomized group
No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions
ECOG performance status of 0-1
Haematological status: absolute neutrophil count(ANC) 1.5109 /L, platelet count(PLT) 100109 /L, hemoglobin(HB) 90 g/L;WBC 3.0109 /L;And no bleeding tendency
Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) 2.5 x upper limit of normal range (ULN), alkaline phosphatase 2.5 x upper limit of normal range (ULN)total bilirubin (TBIL)1.5 x upper limit of normal range (ULN), or3 x upper limit of normal range (ULN) when with Gilbert's syndrome
kidney function: Creatinine(Cr)1.5 x upper limit of normal range(ULN) or Creatinine clearance >60 ml/min (calculated according to Cockroft-Gault)
Able and willing to comply with the study plans in this protocol and sign the informed consent

Exclusion Criteria

Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment
postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome
Patients known to be allergic or intolerant to clinical trial drugs
investigator believes will affect the subject's treatment regimen, uncontrolled serious medical diseases, including severe heart disease (such as the New York Heart Association (NYHA) Level II or more Congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection
Known active infection with HIV, hepatitis B or hepatitis C
Other serious and uncontrolled non-malignant disease; except adequately treated cervical carcinoma in situ, non-melanoma skin Localized prostate cancer after cancer and radical surgery (PSA 10 ng/ml); no recurrence or metastasis was found based on imaging follow-up results and any disease-specific tumor markers
accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation
Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age
The investigator judges patients who are not suitable for the study
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