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Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03986385
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):
Qun Zhao, Hebei Medical University

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 negative adenocarcinoma at gastroesophageal junction.

Condition or disease Intervention/treatment Phase
Gastroesophageal Junction Adenocarcinoma Drug: Apatinib Capecitabine Oxaliplatin Drug: Capecitabine Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Multicenter, Phase III Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ,III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
Estimated Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A(apatinib Xelox)
Preoperative: apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) Postoperative: Capecitabine 1000mg/m2 bid d1-14 q3w 2 cycles
Drug: Apatinib Capecitabine Oxaliplatin
apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w

Active Comparator: B(Xelox)
Preoperative: Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) Postoperative: Capecitabine 1000mg/m2 bid d1-14 q3w 6 cycles
Drug: Capecitabine Oxaliplatin
Preoperative: Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w

Primary Outcome Measures :
  1. The pathological complete response rate(pCR) [ Time Frame: [ Time Frame: within 3 weeks after surgery ] ]
    The lesion disappeared completely by pathology

  2. Disease-free survival(DFS) [ Time Frame: [ Time Frame: 3 year ] ]
    Baseline to measured date of recurrence or death from any cause

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: [ Time Frame: Preoperative ] ]
    Baseline to measured stable disease

  2. Disease Control Rate(DCR) [ Time Frame: [ Time Frame: Preoperative ] ]
    Baseline to measured disease progression

  3. R0-resection rate [ Time Frame: [ Time Frame: within 3 weeks after surgery ] ]
    There was no residual by the microscope

  4. Overall survival (OS) [ Time Frame: [ Time Frame: 3years ] ]
    Baseline to measured date of death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult patients (18 to 70 years old) at the time of voluntarily signing informed consent;
  2. Histologically or cytologically confirmed adenocarcinoma. The her-2 negative was detected by immunohistochemistry or fluorescence in situ hybridization;
  3. Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy;
  4. Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
  5. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  7. Life expectancy greater than or equal to 6 months;
  8. Subject must meet all of the following criteria based on the laboratory tests within 14 days prior to the first dose of study treatment.

(1) Baseline blood indicators meet the following criteria:HB≥80g/L;ANC≥1.5×109/L;PLT≥90×109/L;WBC≥4.0×109/L and ≤15×109/L (2) Baseline biochemical indicators meet the following criteria: ALT and AST≤2.5ULN, but<≤5ULN if the transferanse elevation is due to liver metastases; ALP≤2.5ULN;TBiL≤1.5ULN;Cr≤1.5ULN,Endogenous creatinine clearance rate ˃60 ml/min (Cockcroft-Gault formula);APTT≤1.5ULN,and INR or PT≤1.5ULN.

9.Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10.Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

  1. Allergic to apatinib, capecitabine and oxaliplatin;
  2. The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
  3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg,diastolic blood pressure > 90 mmHg),Uncontrolled coronary heart disease and arrhythmia,classⅢ-Ⅳcardiac insufficiency;
  4. A variety of factors influencing oral drugs (such as unable to swallow, nausea,vomiting,chronic diarrhea and intestinal obstruction, etc);
  5. 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;
  6. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
  7. Pregnant or lactating women;
  8. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
  9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  10. Less than 4 weeks from the last clinical trial;
  11. The researchers think inappropriate.

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Responsible Party: Qun Zhao, Surgical director, Hebei Medical University Identifier: NCT03986385     History of Changes
Other Study ID Numbers: HRA-G04
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors