search
Back to results

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

Primary Purpose

Gastroesophageal Junction Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib
Capecitabine
Oxaliplatin
Radiotherapy
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18 to 70 years old (man or female);
  2. Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;
  3. Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
  4. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

  6. Major organ function has to meet the following certeria:

    HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/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;

  7. Life expectancy greater than or equal to 6 months;
  8. 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;
  9. 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.

Sites / Locations

  • The Fourth Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

apatinib XELOX and radiotherapy

XELOX and radiotherapy

Arm Description

apatinib：250mg qd po XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）

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

Outcomes

Primary Outcome Measures

The pathological complete response rate(pCR)
The lesion disappeared completely by pathology

Secondary Outcome Measures

Objective response rate (ORR)
Baseline to measured stable disease
R0-resection rate
There was no residual by the microscope
Disease-free survival(DFS)
Baseline to measured date of recurrence or death from any cause
Overall survival (OS)
Baseline to measured date of death from any cause
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.

Full Information

First Posted
November 17, 2017
Last Updated
February 18, 2020
Sponsor
Hebei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03349866
Brief Title
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
Official Title
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
apatinib XELOX and radiotherapy
Arm Type
Experimental
Arm Description
apatinib：250mg qd po XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）
Arm Title
XELOX and radiotherapy
Arm Type
Active Comparator
Arm Description
XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
apatinib：250mg qd po
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000mg/m2 bid d1-14
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m2 Ivgtt d1 q3w
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
45Gy/25f （1.8Gy/f/d，5 f/w）
Primary Outcome Measure Information:
Title
The pathological complete response rate(pCR)
Description
The lesion disappeared completely by pathology
Time Frame
within 3 weeks after surgery
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Baseline to measured stable disease
Time Frame
within 3 weeks after surgery
Title
R0-resection rate
Description
There was no residual by the microscope
Time Frame
within 3 weeks after surgery
Title
Disease-free survival(DFS)
Description
Baseline to measured date of recurrence or death from any cause
Time Frame
3 year
Title
Overall survival (OS)
Description
Baseline to measured date of death from any cause
Time Frame
3years
Title
Adverse events
Description
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18 to 70 years old (man or female); Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry; Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC ); Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1); Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Major organ function has to meet the following certeria: HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/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; Life expectancy greater than or equal to 6 months; 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; Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. Exclusion Criteria: Allergic to apatinib, capecitabine and oxaliplatin; The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive; 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; 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 (INR > 1.5 ULN, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qun Zhao
Phone
13930162111
Email
Zhaoqun516@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qun Zhao
Organizational Affiliation
Hebei Medical University Fourth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Wang
Organizational Affiliation
Hebei Medical University Fourth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth Hospital of Hebei Medical University
City
ShiJiaZhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Zhao
Phone
13930162111
Email
Zhaoqun516@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34540013
Citation
Guo H, Li Y, Lin C, Cheng Y, Zhang Z, Wang D, Zhao X, Liu Y, Jing S, Yang P, Tian Y, Liu Y, Wang J, Zhao Q. Efficacy and safety of neoadjuvant chemoradiotherapy plus apatinib for patients with locally advanced, HER2-negative, Siewert's type II-III adenocarcinoma of esophagogastric junction: a single-arm, open-label, phase II trial. Am J Transl Res. 2021 Aug 15;13(8):9015-9023. eCollection 2021.
Results Reference
derived

Learn more about this trial

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

We'll reach out to this number within 24 hrs