An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

NCT03285906 | Unknown Phase 2 DMC

• 1 other identifier: AHEAD-HBE001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric

Conditions

Esophagus Cancer, Stage III; Esophageal Gastric Cardia Type Metaplasia; Esophagus Cancer, Stage IV

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Objective Response Rate

  Through study completion, an average of 0.5 year

• median Overall Survival

  Through study completion, an average of 1.5 year

Study Arms (1)

Treatment group

EXPERIMENTAL

Apatinib：500 mg，po，qd

Drug: Apatinib

Interventions

Apatinib DRUG

Targeted therapy Apatinib：500 mg，po，qd

Also known as: YN968D1

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 75 years of age
• Have failed for 1 lines of chemotherapy
• ECOG performance scale 0 - 2.
• Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min.
• Life expectancy of more than 12 months

You may not qualify if:

• Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
• Any factors that influence the usage of oral administration
• The center of the tumor invaded local large blood vessels
• Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
• Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
• Less than 4 weeks from the last clinical trial

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

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

• Pan Zhanyu, Master

  86-13752570372

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Zhanyu, Master

CONTACT

86-13752570372; liyanwei127@hotmail.com

LI Yanwei, Master

CONTACT

86-13920292059; liyanwei127@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 18, 2017
• Study Start: March 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 18, 2017

Record last verified: 2017-07

Locations

CN (1)