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

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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Neoplasms
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Yangpu District East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Apatinib Treatment; Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	the time with no progression from the treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	the time from the treatment to death	24 weeks
Overall Response Rate	partial response and complete response	4 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: kuaile zhao, doctor, Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: ESO-Shanghai11

Drug and device information, study documents

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