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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)
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Her2 Positive with SOX | Active Comparator | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
|
| Her2 Positive with SOXT | Experimental | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks. |
|
| Her2 Negative with SOX | Active Comparator | Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
|
| Her2 Negative with DOS | Experimental | Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| major Pathological response rate | 40 months |
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Inclusion criteria:
Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;
The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
Chemotherapy and radiotherapy naïve.
Age ≥18 years;
ECOG(Eastern Cooperative Oncology Group ) 0-1;
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;
Left ventricular ejection fraction>50%
Written informed consent.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Ai Zhou, MD | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 10000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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|
| Trastuzumab | Drug | 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. |
|
|
| Oxaliplatin | Drug | 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. |
|
|
| Docetaxel | Drug | 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 |
|
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |