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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135781
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xiangdong Cheng, 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

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: nab paclitaxel Drug: Tegafur Drug: Oxaliplatin Drug: Capecitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: 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 Name: 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 )




Primary Outcome Measures :
  1. 3 years Diseases-free Survival rate(3 years-DFS) [ Time Frame: 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 :
  1. Overall survival (OS) [ Time Frame: up to 3 years ]
    Overall survival is defined as time from the start of treatment until death due to any reason.

  2. Safety as measured by number and grade of adverse events [ Time Frame: up to 3 years ]
    Summary adverse events according to NCI-CTCAE 5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135781


Contacts
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Contact: Cheng xiangdong, PhD 0571-88128041 Chengxd516@126.com
Contact: Yu pengfei, PhD 0571-88128041 ypfzmu@163.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiangdong Cheng, MD,PhD    +86-571-88128202    Chengxd516@126.com   
Principal Investigator: Xiangdong Cheng, MD,PhD         
Sub-Investigator: Yu Pengfei, MD,PhD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Cheng xiangdong, PhD Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences
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Responsible Party: Xiangdong Cheng, Director, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04135781    
Other Study ID Numbers: CSPC-KAL-GC-04
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangdong Cheng, Zhejiang Cancer Hospital:
nab-paclitaxel
gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Oxaliplatin
Tegafur
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites