Status:
UNKNOWN
Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study
Lead Sponsor:
Hebei Medical University
Conditions:
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at...
Eligibility Criteria
Inclusion
- Age:18 to 60 years old (man or female);
- confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
- Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
- Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Major organ function has to meet the following criteria:
- HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; Alanine Transaminase (ALT) and Aspartate Transaminase(AST)≤2.5×ULN, but\<≤5×ULN if the transferase elevation is due to liver metastases； Total Bilirubin(TBIL)\<1.5×ULN； Serum creatinine ≤1.5×ULN;Serum albumin ≥ 30g / L
- Life expectancy greater than or equal to 6 months;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion
- Allergic to trastuzumab, capecitabine and oxaliplatin;
- severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- 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;
- Coagulant function abnormality (International Normalized Ratio(INR) \> 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) \> 1.5 ULN), with bleeding tendency;
- Pregnant or lactating women;
- Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03368131
Start Date
December 1 2017
End Date
December 31 2020
Last Update
February 19 2020
Active Locations (1)
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1
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011