A Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT03320629
Phase
PHASE2
Status
Terminated

Conditions

  • Refractory or Metastatic Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • apatinib S-1 radiotherapy — COMBINATION_PRODUCT
    apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
  • S-1 radiotherapy — COMBINATION_PRODUCT
    S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent

Study Details

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.

Key Dates

Start date
Nov 1, 2017
Status verified
Oct 2017
Primary completion
Nov 1, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib and S-1 radiotherapy
    apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
  • Active Comparator: S-1 radiotherapy
    S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure

Progression free survival [ Time Frame: evaluated in 24 months since the treatment began ]