Status:
COMPLETED
Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell carcinoma patients now, especially after the second-line treatment. Most of the patients have the bad ECOG ...
Eligibility Criteria
Inclusion
- Patient age: ≥18 years old
- An ECOG score of 0-2
- Pathologically diagnosed with Esophageal Squamous Cell Carcinoma.
- At least second-line treatment failure regimens without targeted therapy.
- Measurable lesion.
- An expected survival of ≥ 3 months.
- Major organ function had to meet the following criteria:
- 1)For regular test results: HB(hemoglobin) ≥ 90g / L (14 days without blood transfusion); ANC(absolute neutrophil count) ≥ 1.5 × 109 / L; PLT(platelet) ≥ 80 × 109 / L 2)Biochemical tests results: Bilirubin \<1.5 times the upper limit of normal (ULN) ALT(Alanine aminotransferase) and AST≤2.5 × ULN; liver metastases, if any, the ALT and AST≤5 × ULN; Endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula) 8. Informing consent.
Exclusion
- Previously or presently suffering from other malignancies, except for the cured and stable carcinoma;
- Pregnant or lactating women;
- Participation in clinical trials with other drugs in the preceding four weeks.
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
- Serious bleeding events within 4weeks (≥3 degree)-CTCAE(Common Terminology Criteria for Adverse Events) 4.0
- Central nervous system metastasis or a history of central nervous system metastasis.
- Hypertension and antihypertensive drug treatment that does not normalize blood pressures (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg); With unstable angina pectoris; Arrhythmia; Coronary heart disease greater than Class II; Angina pectoris diagnosed with 3 months or myocardial infarction event occurs within 6 months before recruiting.
- With the open wounds or fractura.
- A history of organ transplant.
- Coagulation dysfunction (PT(prothrombin time)\>16 s, APTT(activated partial thromboplastin time)\>43 s, TT(thrombin time)\>21 s, Fbg(Fibrinogen)\<2g/L), a tendency to bleed or receiving thrombolytic or anticoagulant therapy.
- A history of abuse of psychotropic drugs or mental disorders.
- Central nervous system disorders.
- A history of immunodeficiency.
- Arterial/venous thrombosis events within 12 months before recruiting.
- Use of CFDA(China Food and Drug Administration) approved anti-gastric modern traditional Chinese medicine preparations and immunomodulatory agents.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03274011
Start Date
July 1 2017
End Date
June 26 2019
Last Update
January 26 2021
Active Locations (1)
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1
Shanghai Yangpu District East Hospital
Shanghai, Shanghai Municipality, China, 200433