Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction

Sponsor
Hebei Medical University
Study ID
NCT03986385
Phase
PHASE3
Status
Unknown

Conditions

  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Apatinib Capecitabine Oxaliplatin — DRUG
    apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w
  • Capecitabine Oxaliplatin — DRUG
    Preoperative: Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w

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
Jun 1, 2019
Status verified
Feb 2020
Primary completion
Jun 30, 2020
Completion
Jan 31, 2021

Study Design

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

Arms

  • 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
  • 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

Primary Outcome Measure

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

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