A Phase 2 interventional study of apatinib S-1 radiotherapy and S-1 radiotherapy in Refractory or Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Hebei Medical University Fourth Hospital. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Hebei Medical University Fourth Hospital · Phase 2, Interventional, and Treatment
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.
1. Age:18 to 70 years old (man or female); 2. Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence ); 3. The distant metastatic is oligotransfera, with radiotherapy indication; 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 0-2; 6. Major organ function has to meet the following certeria:
For results of blood routine test (without blood transfusion within 14 days)
For results of blood biochemical test:
<!-- -->
Exclusion Criteria:
1. Allergic to apatinib; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease and arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac insufficiency; 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with tendency of gastrointestinal bleeding, including the following;
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
Combination Product: apatinib 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
Combination Product: 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
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
Progression free survival
Baseline to measured date of progression or death from any cause
Time frame: evaluated in 24 months since the treatment began
Overall survival
Baseline to measured date of death from any cause
Time frame: the first day of treatment to death or last survival confirm date,up to 24 months
Disease control rate
Baseline to measured progressive disease
Time frame: tumor assessment every 6 weeks ,up to 24 month
Objective response rate
Baseline to measured stable disease
Time frame: tumor assessment every 6 weeks,up to 24 months
Side effects
throughout study
Time frame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Esophageal Squamous Cell Carcinoma→
Hebei Medical University Fourth Hospital