Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma Read More

Inclusion Criteria:

• Histologically or cytologically confirmed Stage IIIB or IV ESCC
• At least experienced one regimens of chemotherapy prior to study
• Histological or cytological evidence of EGFR overexpression or gene copy number increased
• Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
• Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Life expectancy of ≥ 12 weeks
• Adequate organ function
• Subject Consent
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to performing this study.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

• Prior treatments
• EGFR targeted therapy, or major surgery within 4 weeks prior to study treatment
• Nitrosourea and mitomycin chemotherapy within 6 weeks prior to study treatment
• Had received any investigational agent from other clinical study within 4 weeks prior to study treatment or are currently participating in other clinical trials
• Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction);
• Symptomatic, untreated or unstable central nervous system metastases (patient are only permitted if treated, asymptomatic and stable for at least 4 weeks prior to start of study treatment)
• History of interstitial lung disease
• Uncontrolled hypertension that require more than two anti-hypertensive agents to control, or systolic blood pressure (BP) >140mmHg or diastolic BP >90 mmHg before the first administration
• Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%
• Male with QTc interval > 450 ms or female with QTc interval > 470 ms
• History of immunodeficiency, or other acquired or congenital immunodeficiency, or history of organ transplantation
• Any disease of the following bellowed within 6 months prior to administration:

Myocardial infarction, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure, or cerebrovascular events (including transient ischemic attack)

• Active infection of hepatitis B virus (HBV)/hepatitis C virus (HCV), or infection of Human immunodeficiency virus (HIV)
• Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
• History of serious allergic reactions attributed to excipients of Z650, including mannitol, sodium carboxymethyl starch, aerosol, magnesium stearate and silicified microcrystalline cellulose
• Pregnant women, or patients not agree to use of effective contraceptions during the study or within 6 month after the study
• Any other reason the investigator considers the patient is not suitable to participate in the study