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出境医 / 临床实验 / Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction

Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction

Study Description
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

Study Design
Layout table for study information
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
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 31, 2021
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
China, Hebei
QunZhao Recruiting
Shijia Zhuang, Hebei, China
Contact: Qun Zhao    8613930162111    zhaoqun@hebmu.edu.cn   
Sponsors and Collaborators
Hebei Medical University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • The pathological complete response rate(pCR) [ Time Frame: [ Time Frame: within 3 weeks after surgery ] ]
    The lesion disappeared completely by pathology
  • Disease-free survival(DFS) [ Time Frame: [ Time Frame: 3 year ] ]
    Baseline to measured date of recurrence or death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Objective response rate (ORR) [ Time Frame: [ Time Frame: Preoperative ] ]
    Baseline to measured stable disease
  • Disease Control Rate（DCR） [ Time Frame: [ Time Frame: Preoperative ] ]
    Baseline to measured disease progression
  • R0-resection rate [ Time Frame: [ Time Frame: within 3 weeks after surgery ] ]
    There was no residual by the microscope
  • Overall survival (OS) [ Time Frame: [ Time Frame: 3years ] ]
    Baseline to measured date of death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • Drug: Apatinib Capecitabine Oxaliplatin
    apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w
  • Drug: Capecitabine Oxaliplatin
    Preoperative: Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w
Study Arms  ICMJE
  • 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
    Intervention: Drug: Apatinib Capecitabine Oxaliplatin
  • 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
    Intervention: Drug: Capecitabine Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986385
Other Study ID Numbers  ICMJE HRA-G04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qun Zhao, Hebei Medical University
Study Sponsor  ICMJE Hebei Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hebei Medical University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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