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

January 3, 2022 updated by: Xianglin Yuan, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xianglin Yuan, MD,PHD
        • Sub-Investigator:
          • Hong Qiu, MD,PHD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 years
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.
up to 3 years
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).
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Xianglin Yuan, MD,PhD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJCC008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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