Clinical trial NCT03320629: A Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
Official title: A Prospective Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Refractory or Metastatic Esophageal Squamous Cell Carcinoma
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Progression free survival
timeFrame: evaluated in 24 months since the treatment began
Secondary outcomes:
measure: Overall survival
timeFrame: the first day of treatment to death or last survival confirm date，up to 24 months
measure: Disease control rate
timeFrame: tumor assessment every 6 weeks ，up to 24 month
measure: Objective response rate
timeFrame: tumor assessment every 6 weeks，up to 24 months
measure: Side effects
timeFrame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References: