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Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

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: NCT03801668
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xianglin Yuan, Huazhong University of Science and Technology

Brief Summary:
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Albumin-bound Paclitaxel plus S-1 Drug: Oxaliplatin plus S-1 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nab-P/S-1
Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
Drug: Albumin-bound Paclitaxel plus S-1
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.

Active Comparator: SOX
Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
Drug: Oxaliplatin plus S-1
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 3 years ]
    PFS is defined as time from the start of treatment to progression of disease or death.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  2. 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.

  3. Safety as measured by number and grade of adverse events [ Time Frame: up to 3 years ]
    Summary adverse events according to NCI-CTCAE 4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
  3. At least one measurable lesion as defined by RECIST 1.1 criteria;
  4. ECOG performance status of 0-1;
  5. Estimated life expectancy of at least 3 months;
  6. Left ventricular ejection fraction (LVEF) ≥ 50%;
  7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
  8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases,total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
  9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
  10. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion Criteria:

  1. Have received chemotherapy before;patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
  2. HER-2 positive;
  3. Patients with symptomatic brain metastases;
  4. II-IV peripheral neuropathy [NCI-CTCAE 4.03];
  5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
  6. Patients with serious systemic infection or other diseases;
  7. Allergic to the chemotherapy drugs or the materials in this study;
  8. Patients with gastrointestinal bleeding that need clinical intervention;
  9. Patients with digestive tract obstruction or oral nutrition difficulty;
  10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
  11. Have participated in other clinical trials within 28 days prior to the first dose of this study;
  12. Contraindications to chemotherapy;
  13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.

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): NCT03801668


Contacts
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Contact: Xianglin Yuan, MD,PhD 8627-83663406 xlyuan1020@163.com
Contact: Hong Qiu, MD,PhD 8627-83663406 tjqiuhong@163.com

Locations
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China, Hubei
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Xianglin Yuan, MD,PHD    8627-83663406    xlyuan1020@163.com   
Contact: Hong Qiu, MD,PHD    8627-83663406    tjqiuhong@163.com   
Principal Investigator: Xianglin Yuan, MD,PHD         
Sub-Investigator: Hong Qiu, MD,PHD         
Sponsors and Collaborators
Huazhong University of Science and Technology
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Xianglin Yuan, MD,PhD Tongji Hospital

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Responsible Party: Xianglin Yuan, Professor, Head of the cancer center, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03801668    
Other Study ID Numbers: TJCC008
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Xianglin Yuan, Huazhong University of Science and Technology:
Gastric Cancer
Albumin-bound Paclitaxel
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action