Gastric Cancer
Conditions
Keywords
Gastric Cancer, Albumin-bound Paclitaxel
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.
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.
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | up to 3 years | The rate of participants that achieve either a complete response (CR) or a partial response (PR). |
| Overall survival (OS) | 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 | up to 3 years | Summary adverse events according to NCI-CTCAE 4.03 |
Countries
China
Contacts
Primary ContactXianglin Yuan, MD,PhD
Backup ContactHong Qiu, MD,PhD
Outcome results
None listed