Gastric Cancer
Conditions
Brief summary
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status. The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
Detailed description
(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team. (HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
Interventions
DRUGS-1
Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.
DRUGTrastuzumab
Her-2 positive patients with SOXT Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Trastuzumab: 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1 Every 3 weeks.
DRUGOxaliplatin
Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.
DRUGDocetaxel
Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma; 2. The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); * HER2 positive: IHC 3+ or IHC 2+/ FISH amplification. * HER2 negative: IHC 0, 1+ or IHC 2+/ FISH without amplification. 3. T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma; 4. Chemotherapy and radiotherapy naïve. 5. Age ≥18 years; 6. ECOG(Eastern Cooperative Oncology Group ) 0-1; 7. Adequate hematological, hepatic and renal functions: absolute neutrophil count (ANC) ≥ 2.0 G/L, hemoglobin ≥ 90g/L, platelet ≥ 100 G/L; ALT and AST \<1.5 times x upper limit of normal (ULN)；serum total bilirubin \< 1.0 x ULN; serum creatinine \< 1.0 x ULN; 8. Left ventricular ejection fraction\>50% 9. Written informed consent.
Exclusion criteria
1. Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma 2. History of allergies to drugs in the study 3. Intraperitoneal dissemination or distant metastasis 4. Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites 5. Dysphagia 6. Any cause of cirrhosis 7. Cardiac function NYHA(New York Heart Association) \>I degrees 8. Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia 9. Any surgical contraindication 10. Any chemotherapy or radiotherapy history 11. Any surgical resection history of gastric cancer 12. History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix 13. Any contraindication for chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major Pathological response rate | 40 months |
Countries
China
Outcome results
None listed