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

Phase 3

Recruiting

• Conditions: Stomach Cancer
• Interventions: Drug: nab paclitaxel; Drug: Oxaliplatin; Drug: Tegafur; Drug: Capecitabine

• Registration Number: NCT04135781
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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 Ⅲ gastric cancer as adjuvant setting

Detailed 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 Ⅲ 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.

Study Timeline

• Study First Submitted: 2019-10-20
• Study First Submitted QC: 2019-10-20
• Study First Posted: 2019-10-23
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-23
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

1. Age of 18-75 years;
2. Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach;
3. Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline;;
4. Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved;
5. Ability to perform chemotherapy within 7 days of enrollment in the randomized group;
6. No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions;
7. ECOG performance status of 0-1;
8. Haematological status: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥100×109 /L, hemoglobin(HB) ≥90 g/L;WBC ≥3.0×109 /L;And no bleeding tendency;
9. 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), or≤3 x upper limit of normal range (ULN) when with Gilbert's syndrome;
10. kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance >60 ml/min (calculated according to Cockroft-Gault)
11. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion Criteria

1. Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment;
2. postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome;
3. Patients known to be allergic or intolerant to clinical trial drugs;
4. 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；
5. Known active infection with HIV, hepatitis B or hepatitis C;
6. 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;
7. accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation;
8. Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age;
9. The investigator judges patients who are not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AS	nab paclitaxel	Arm A：nab paclitaxel （120mg/m2；iv；d1，8）+S-1 （\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）Q3W；up to eight cycles
XELOX	Oxaliplatin	Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles
AS	Tegafur	Arm A：nab paclitaxel （120mg/m2；iv；d1，8）+S-1 （\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）Q3W；up to eight cycles
XELOX	Capecitabine	Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles

Primary Outcome Measures

Name	Time	Method
3 years Diseases-free Survival rate(3 years-DFS)	up to 3 years	DFS is defined as time from the date of inclusion up to the date of disease progression or death

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 3 years	Overall survival is defined as time from the start of treatment until death due to any reason.
Safety as measured by number and grade of adverse events	up to 3 years	Summary adverse events according to NCI-CTCAE 5.0

Trial Locations

Locations (1)

Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences; 🇨🇳 Hangzhou, Zhejiang, China