Clinical trial NCT03801668: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Albumin-bound Paclitaxel
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-01-11
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to 3 years
measure: Overall survival (OS)
timeFrame: up to 3 years
measure: Safety as measured by number and grade of adverse events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xianglin Yuan, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.