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

Sponsor
Hebei Medical University
Study ID
NCT03349866
Phase
PHASE2
Status
Unknown

Conditions

  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2017
Status verified
Feb 2020
Primary completion
Nov 30, 2019
Completion
Nov 30, 2020

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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）
  • Active Comparator: 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）

Primary Outcome Measure

The pathological complete response rate(pCR) [ Time Frame: within 3 weeks after surgery ]

Central Contacts

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