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

NCT ID: NCT03368131

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-12-31

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 gastroesophageal junction

Conditions

Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab XELOX and radiotherapy

Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle. XELOX：Capecitabine 825\~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45 Gray (unit)Gy/25f （1.8Gy/f/d，5 f/w）

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle

Capecitabine

Intervention Type: DRUG

825\~1000mg/m2 bid d1-14

Oxaliplatin

Intervention Type: DRUG

130 mg/m2 Ivgtt d1 q3w

Radiotherapy

Intervention Type: RADIATION

45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

XELOX and radiotherapy

Capecitabine：825\~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

825\~1000mg/m2 bid d1-14

Oxaliplatin

Intervention Type: DRUG

130 mg/m2 Ivgtt d1 q3w

Radiotherapy

Intervention Type: RADIATION

45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

Interventions

Trastuzumab

intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle

Intervention Type: DRUG

Capecitabine

825\~1000mg/m2 bid d1-14

Intervention Type: DRUG

Oxaliplatin

130 mg/m2 Ivgtt d1 q3w

Intervention Type: DRUG

Radiotherapy

45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qun Zhao

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Jun Wang

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

Alien Crafe 0005

Identifier Type: -

Identifier Source: org_study_id