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

NCT03274011 | Completed Phase 2

• 1 other identifier: ESO-Shanghai11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  the time with no progression from the treatment

  12 weeks

Secondary Outcomes (2)

• Overall Survival

  24 weeks

• Overall Response Rate

  4 weeks

Study Arms (1)

Apatinib Treatment

EXPERIMENTAL

Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Drug: Apatinib

Interventions

Apatinib DRUG

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.

Apatinib Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• )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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Yangpu District East Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• kuaile zhao, doctor

  Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Chest Radiation Oncology Department, Fudan University Cancer Center, Shanghai, P.R. China

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: September 6, 2017
• Study Start: July 1, 2017
• Primary Completion: March 15, 2019
• Study Completion: June 26, 2019
• Last Updated: January 26, 2021

Record last verified: 2019-02

Locations

CN (1)