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

NCT ID: NCT03349866

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2020-11-30

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.

Conditions

Gastroesophageal Junction Adenocarcinoma

Study Design

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

Study Groups

apatinib XELOX and radiotherapy

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）

Group Type: EXPERIMENTAL

apatinib

Intervention Type: DRUG

apatinib：250mg qd po

Capecitabine

Intervention Type: DRUG

1000mg/m2 bid d1-14

Oxaliplatin

Intervention Type: DRUG

130 mg/m2 Ivgtt d1 q3w

Radiotherapy

Intervention Type: RADIATION

45Gy/25f （1.8Gy/f/d，5 f/w）

XELOX and radiotherapy

XELOX：Capecitabine 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

1000mg/m2 bid d1-14

Oxaliplatin

Intervention Type: DRUG

130 mg/m2 Ivgtt d1 q3w

Radiotherapy

Intervention Type: RADIATION

45Gy/25f （1.8Gy/f/d，5 f/w）

Interventions

apatinib

apatinib：250mg qd po

Intervention Type: DRUG

Capecitabine

1000mg/m2 bid d1-14

Intervention Type: DRUG

Oxaliplatin

130 mg/m2 Ivgtt d1 q3w

Intervention Type: DRUG

Radiotherapy

45Gy/25f （1.8Gy/f/d，5 f/w）

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qun Zhao

Role: CONTACT

Zhaoqun516@126.com

13930162111

Facility Contacts

Qun Zhao

Role: primary

Zhaoqun516@126.com

13930162111

References

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.

Reference Type: DERIVED

PMID: 34540013 (View on PubMed)

Other Identifiers

HRA-G01

Identifier Type: -

Identifier Source: org_study_id