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

Adjuvant Nab-paclitaxel Plus S-1 Versus Capecitabine Plus Oxaliplatin for Patients With Stage III Gastric Cancer After D2 Gastrectomy : a Randomised，Open-label, Phase III Study

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

Study Overview

• Status: Recruiting
• Conditions: Stomach Cancer
• Intervention / Treatment: Drug: nab paclitaxel; Drug: Tegafur; Drug: Oxaliplatin; Drug: Capecitabine

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 Type: Interventional
• Enrollment (Anticipated): 616
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cheng xiangdong, PhD; Phone Number: 0571-88128041; Email: Chengxd516@126.com
• Study Contact Backup: Name: Yu pengfei, PhD; Phone Number: 0571-88128041; Email: ypfzmu@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences
      • Contact: Xiangdong Cheng, MD，PhD; Phone Number: +86-571-88128202; Email: Chengxd516@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AS; 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	Drug: nab paclitaxel; nab paclitaxel （120mg/m2；iv；d1，8）; Other Names: albumin bound paclitaxel; Drug: Tegafur; 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）; Other Names: S-1
Active Comparator: XELOX; Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles	Drug: Oxaliplatin; Oxaliplatin（130mg/m2 , iv, d1）; Drug: Capecitabine; Capetabine（1000 mg/m2 po, d1-14 bid ）

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Cheng xiangdong, PhD, Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

Publications and helpful links

General Publications

• Cheng X, Wu D, Xu N, Chen L, Yan Z, Chen P, Zhou L, Yu J, Cui J, Li W, Wang C, Feng W, Wei Y, Yu P, Du Y, Ying J, Xu Z, Yang L, Zhang Y. Adjuvant albumin-bound paclitaxel combined with S-1 vs. oxaliplatin combined with capecitabine after D2 gastrectomy in patients with stage III gastric adenocarcinoma: a phase III multicenter, open-label, randomized controlled clinical trial protocol. BMC Cancer. 2021 Jan 12;21(1):56. doi: 10.1186/s12885-020-07772-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: gastric cancer; nab-paclitaxel
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Capecitabine; Oxaliplatin; Albumin-Bound Paclitaxel; Tegafur
• Other Study ID Numbers: CSPC-KAL-GC-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No