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TerminatedNCT03320629Updated Aug 6, 2025

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

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

Why this study was terminated
This study was voluntarily terminated after investigator assessment, with no safety concerns identified related to the trial intervention or procedures. The primary reason for termination was difficulty in patient recruitment.
Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Refractory or Metastatic Esophageal Squamous Cell Carcinoma
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. For results of blood routine test (without blood transfusion within 14 days)

      1. HB≥100g/L;
      2. ANC≥3.0×109/L;
      3. PLT≥100×109/L;
    2. For results of blood biochemical test:

      1. TBIL\<1.5×ULN;
      2. ALT and AST\<2.5×ULN, but\< 5×ULN if the transferanse elevation is due to liver metastases;
      3. Serum creatinine ≤1ULN , calculated creatinine clearance>50 ml/min(per the Cockcroft-Gault formula); 7. Life expectancy greater than or equal to 3 months; 8. 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; 9. Coagulation function is normal, without active hemorrhage and thrombosis:

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      1. INR\<1.5×ULN
      2. APTT\<1.5×ULN
      3. PT\<1.5ULN 10. Participants were willing to join in this study, and written informed consent; 11. Participants were good adherence, cooperate with the follow-up.

Exclusion criteria

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;

    1. Active ulcerative lesions, and defecate occult blood (+ +);
    2. Has melena and hematemesis in three months;
    3. For defecate occult blood (+) or(+/-) ,must be received gastroscopy, the physicians consider there are potential bleeding risk with ulcers, hemorrhagic diseases; 5. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. Patients with thrombosis or anticoagulant drug therapy; 7. Patients with symptoms of central nervous system metastasis; Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 8. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 9. Less than 4 weeks from the last clinical trial; 10. Have received prior treatment with anti- VEGF/VEGFR; 11. Researchers considered there are serious harm to patient safety or affect the patients who have completed the study; 12. Pregnant or lactating women; 13. The researchers think inappropriate.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study 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

    Combination Product: apatinib S-1 radiotherapy

  • 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

    Combination Product: S-1 radiotherapy

Interventions

  • Combination productapatinib 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

  • Combination productS-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

05

What researchers measure

Primary outcomes

  1. Progression free survival

    Baseline to measured date of progression or death from any cause

    Time frame: evaluated in 24 months since the treatment began

Secondary outcomes

  1. 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

  2. Disease control rate

    Baseline to measured progressive disease

    Time frame: tumor assessment every 6 weeks ,up to 24 month

  3. Objective response rate

    Baseline to measured stable disease

    Time frame: tumor assessment every 6 weeks,up to 24 months

  4. 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

06

Study locations

1 site
  • Fourth Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
07

Registry details

Key details

Study ID
NCT03320629
Lead sponsor
Hebei Medical University Fourth Hospital
Responsible party
Jun wang (Director of radiotherapy department1, Hebei Medical University Fourth Hospital) — Principal investigator
First posted
Oct 25, 2017
Start date
Nov 1, 2017
Primary completion
Nov 1, 2017
Completion
Dec 31, 2018
Last update
Aug 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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