Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Esophageal Neoplasms Clinical Trial

Official title:

Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: A Phase II, Prospective, Single-arm, Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274011
• Other study ID #: ESO-Shanghai11
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: February 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy, radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib treatment significantly improved OS(overall survival) and PFS(progression-free survival) with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 26, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient age: =18 years old

2. An ECOG score of 0-2

3. Pathologically diagnosed with Esophageal Squamous Cell Carcinoma.

4. At least second-line treatment failure regimens without targeted therapy.

5. Measurable lesion.

6. An expected survival of = 3 months.

7. 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 Criteria:

1. Previously or presently suffering from other malignancies, except for the cured and stable carcinoma;

2. Pregnant or lactating women;

3. Participation in clinical trials with other drugs in the preceding four weeks.

4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).

5. Serious bleeding events within 4weeks (=3 degree)-CTCAE(Common Terminology Criteria for Adverse Events) 4.0

6. Central nervous system metastasis or a history of central nervous system metastasis.

7. 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.

8. With the open wounds or fractura.

9. A history of organ transplant.

10. 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.

11. A history of abuse of psychotropic drugs or mental disorders.

12. Central nervous system disorders.

13. A history of immunodeficiency.

14. Arterial/venous thrombosis events within 12 months before recruiting.

15. Use of CFDA(China Food and Drug Administration) approved anti-gastric modern traditional Chinese medicine preparations and immunomodulatory agents.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Apatinib
Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.

Locations

Country	Name	City	State
China	Shanghai Yangpu District East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	the time with no progression from the treatment	12 weeks
Secondary	Overall Survival	the time from the treatment to death	24 weeks
Secondary	Overall Response Rate	partial response and complete response	4 weeks