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

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

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.

Study Overview

• Status: Terminated
• Conditions: Refractory or Metastatic Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Combination product: apatinib S-1 radiotherapy; Combination product: S-1 radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:
     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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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	Combination product: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Baseline to measured date of progression or death from any cause	evaluated in 24 months since the treatment began

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Baseline to measured date of death from any cause	the first day of treatment to death or last survival confirm date，up to 24 months
Disease control rate	Baseline to measured progressive disease	tumor assessment every 6 weeks ，up to 24 month
Objective response rate	Baseline to measured stable disease	tumor assessment every 6 weeks，up to 24 months
Side effects	throughout study	evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HRA-E01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No