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Status unknownNCT03801668Updated Jan 4, 2022

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

A Phase 3 interventional study of Albumin-bound Paclitaxel plus S-1 and Oxaliplatin plus S-1 in Gastric Cancer, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Huazhong University of Science and Technology · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
294
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer

Keywords

  • Gastric Cancer
  • Albumin-bound Paclitaxel
03

In context

Adenocarcinoma

2,002 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 294 is above the median of 45 across 1,551 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 242 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
294 participants (estimated)

Study arms

  • 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

  • Active comparator
    SOX

    Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.

    Drug: Oxaliplatin plus S-1

Interventions

  • DrugAlbumin-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.

  • DrugOxaliplatin plus S-1

    Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    PFS is defined as time from the start of treatment to progression of disease or death.

    Time frame: up to 3 years

Secondary outcomes

  1. Overall Response Rate (ORR)

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

    Time frame: up to 3 years

  2. Overall survival (OS)

    Overall survival is defined as time from the start of treatment until death due to any reason.

    Time frame: up to 3 years

  3. Safety as measured by number and grade of adverse events

    Summary adverse events according to NCI-CTCAE 4.03

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    • Xianglin Yuan, MD,PHD · Contact · xlyuan1020@163.com · 8627-83663406
    • Hong Qiu, MD,PHD · Contact · tjqiuhong@163.com · 8627-83663406
    • Xianglin Yuan, MD,PHD · Principal investigator
    • Hong Qiu, MD,PHD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022. PubMed 35983025 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03801668
Lead sponsor
Huazhong University of Science and Technology
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
Responsible party
Xianglin Yuan (Professor, Head of the cancer center, Huazhong University of Science and Technology) — Principal investigator
First posted
Jan 11, 2019
Start date
Mar 8, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Jan 4, 2022

Study contacts

Xianglin Yuan, MD,PhD
Contact
xlyuan1020@163.com
8627-83663406
Hong Qiu, MD,PhD
Contact
tjqiuhong@163.com
8627-83663406
Xianglin Yuan, MD,PhD
study chair · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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