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

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03801668
Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)
294
1
2
48.8
6

Study Details

Study Description

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
  • Drug: Albumin-bound Paclitaxel plus S-1
  • Drug: Oxaliplatin plus S-1
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 8, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free Survival (PFS) [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) [up to 3 years]

    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  2. Overall survival (OS) [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 [up to 3 years]

    Summary adverse events according to NCI-CTCAE 4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030

Sponsors and Collaborators

  • Huazhong University of Science and Technology
  • CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 11, 2019
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xianglin Yuan, Professor, Head of the cancer center, Huazhong University of Science and Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022