adenocarcinoma at gastroesophageal junction
Conditions
Interventions
Experimental:Trastuzumab XELOX and radiotherapy
Control:XELOX and radiotherapy
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years male and female; 2. Has been confirmed with Siewert II, III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or FISH; 3. Patients with stage III by EUS, CT (or PET-CT) and laparoscopic (According to the eighth edition of AJCC ); 4. Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5. Major organ function has to meet the following certeria: HB=80g/L; ANC=1.5×10^9/L; PLT=90×10^9/L; ALT and AST=2.5×ULN, but<=5×ULN if the transferanse elevation is due to liver metastases TBIL<1.5×ULN Serum creatinine =1.5×ULN; Serum albumin = 30g/L; 6. Life expectancy greater than or equal to 6 months; 7. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergic to trastuzumab, capecitabine and oxaliplatin; 2. severe diseases such as liver and kidneymyocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmiawhich affect the situation of chemotherapy or surgery 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 4, Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; 5. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. Pregnant or lactating women; 7. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ); 8. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 9. Less than 4 weeks from the last clinical trial; 10. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pathological complete response rate(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease-free survival(DFS);Disease Control Rate (DCR);Percentage of Participants With Objective Response;Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score; | — |
Countries
China
Contacts
Public ContactQun Zhao
Fourth Hospital of Hebei Medical University
Outcome results
None listed