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

STATUS

Recruiting
End date

Oct 31, 2024
participants needed

616
sponsor

Zhejiang Cancer Hospital

Send

Updated on 1 March 2022

See if I qualify

platelet count

gastrectomy

paclitaxel

oxaliplatin

gastric adenocarcinoma

neutrophil count

capecitabine

cancer chemotherapy

adenocarcinoma

adjuvant chemotherapy

tegafur

immunostimulants

xelox regimen

Summary

Description

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.

Details

Condition	Stomach Cancer
Treatment	Capecitabine, Oxaliplatin, nab paclitaxel, Tegafur
Clinical Study Identifier	NCT04135781
Sponsor	Zhejiang Cancer Hospital
Last Modified on	1 March 2022

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