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

• ClinicalTrials.gov Identifier: NCT03801668
• Recruitment Status: Unknown
• First Posted: January 11, 2019
• Last Update Posted: January 4, 2022
• Sponsor: Huazhong University of Science and Technology
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Xianglin Yuan, Huazhong University of Science and Technology

Tracking Information

• First Submitted Date: January 7, 2019
• First Posted Date: January 11, 2019
• Last Update Posted Date: January 4, 2022
• Actual Study Start Date: March 8, 2019
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 10, 2019)

• 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).
• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

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

Study Arms

• Experimental: Nab-P/S-1
  Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
  Intervention: Drug: Albumin-bound Paclitaxel plus S-1
• Active Comparator: SOX
  Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
  Intervention: Drug: Oxaliplatin plus S-1

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 10, 2019): 294
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03801668
• Other Study ID Numbers: TJCC008
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Xianglin Yuan, Huazhong University of Science and Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: Huazhong University of Science and Technology
• Original Study Sponsor: Same as current
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

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

• PRS Account: Huazhong University of Science and Technology
• Verification Date: January 2022