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

Phase 2

• Conditions: Refractory or Metastatic Esophageal Squamous Cell Carcinoma
• Interventions: Combination Product: S-1 radiotherapy; Combination Product: apatinib S-1 radiotherapy

• Registration Number: NCT03320629
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-25
• Study Start: 2017-11-01
• Last Update Submitted: 2018-01-14
• Last Update Posted: 2018-01-17
• Primary Completion: 2019-10
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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:

  2. 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;

  3. 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

• 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;

  2. Active ulcerative lesions, and defecate occult blood (+ +);

  3. Has melena and hematemesis in three months;

  4. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-1 radiotherapy	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
apatinib and S-1 radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Progression free survival	evaluated in 24 months since the treatment began	Baseline to measured date of progression or death from any cause

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China