Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction

NCT03986385 | Unknown Phase 3

• 1 other identifier: HRA-G04
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The pathological complete response rate(pCR)

  The lesion disappeared completely by pathology

  [ Time Frame: within 3 weeks after surgery ]

• Disease-free survival(DFS)

  Baseline to measured date of recurrence or death from any cause

  [ Time Frame: 3 year ]

Secondary Outcomes (4)

• Objective response rate (ORR)

  [ Time Frame: Preoperative ]

• Disease Control Rate（DCR）

  [ Time Frame: Preoperative ]

• R0-resection rate

  [ Time Frame: within 3 weeks after surgery ]

• Overall survival (OS)

  [ Time Frame: 3years ]

Study Arms (2)

A(apatinib Xelox)

EXPERIMENTAL

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

B(Xelox)

ACTIVE COMPARATOR

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

Interventions

Apatinib Capecitabine Oxaliplatin DRUG

apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w

A(apatinib Xelox)

Capecitabine Oxaliplatin DRUG

Preoperative: Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w

B(Xelox)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 to 70 years old) at the time of voluntarily signing informed consent;
• Histologically or cytologically confirmed adenocarcinoma. The her-2 negative was detected by immunohistochemistry or fluorescence in situ hybridization;
• Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy;
• 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;
• Life expectancy greater than or equal to 6 months;
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

QunZhao

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Interventions

XELOX

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical director

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: January 31, 2021
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

CN (1)