Esophageal squamous cell carcinoma
Conditions
Interventions
Case series:Before breakfast, take the capsule of erlotinib hydrochloride on an empty stomach once a day, 1 capsule (12mg). Continuous oral administration for 2 weeks, 1 week, ie 3 weeks (21 days) for
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to participate in the study, signed informed consent; 2. histological or cytological diagnosis of advanced esophageal squamous cell carcinoma, unsuitable for surgery; 3. measurable lesions (RECIST 1.1); 4. failure of first-line treatment Patients (Definition of treatment failure: toxic side effects are intolerable, disease progression during treatment or recurrence within 6 months after treatment); 5. Aged 18-80 years, ECOG PS score 0-1, expected survival over 3 Months; 6. The main organs function well, within 7 days before the intervention, meet the following criteria: (1) blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) = 90g / L; Absolute granulocyte count (ANC) = 1.5 × 10^9 / L; platelets (PLT) = 80 × 10^9/L; (2) Biochemical examinations are subject to the following criteria: total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5ULN ALT = 2.5ULN, such as with liver metastasis, ALT and AST = 5ULN; serum creatinine (Cr) = 1.5ULN or creatinine clearance (CCr) = 60ml / min (calculated according to the Cockroft-Gault formula); (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = normal low limit (50%); 7. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment, It must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period.
Exclusion criteria
Exclusion criteria: 1) Patients who have previously used erlotinib HCl; 2) have had or have other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [ Ta (non-invasive tumor), Tis (in situ carcinoma) and T1 (tumor infiltrating basement membrane)]; 3) planned systemic anti-tumor therapy, including cytotoxic therapy, within 4 weeks prior to enrollment or during the study , signal transduction inhibitors, immunotherapy (or mitomycin C used within 6 weeks prior to receiving the test drug); 4) have multiple factors affecting oral medications (eg, dysphagia, pyloric obstruction, intestinal obstruction, and Patients with chronic diarrhea, etc.; 5) Patients with severe disease or symptoms affecting survival time (less than 3 months) or completed; 6) Patients with any severe and/or uncontrolled diseases, including: a) Unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); b) with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc =480ms) and =2 grade congestive heart failure (New York heart disease) Association (NYHA) classification); c) activity Uncontrolled serious infection (=CTC AE grade 2 infection); d) cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; e) renal failure requires hemodialysis or peritoneal dialysis; f) a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; g) poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); h) Urinary routine indicates urinary protein = ++, and confirmed 24-hour urine protein quantitation > 1.0 g; i) patients with seizures and need treatment; 7) major surgical treatment, incisional biopsy or significant trauma within 28 days before grouping Sexual injury; 8) Imaging studies indicate that the tumor has invaded an important blood vessel or that the patient is likely to invade the important blood vessel during the follow-up study and cause fatal bleeding; 9) Regardless of the severity, there is any sign or history of bleeding. Patients; any hemorrhage or bleeding episode =CTCAE level 3 in the first 4 weeks prior to grouping, there were unhealed wounds, ulcers or fractures; 10) Overactivity/vein occurred within 6 months Thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 11) those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 12) participated in other subjects within 4 weeks Clinical trial of anti-tumor drugs; 13) According to the investigator, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;Overall survival;Quality of Life;Occurrence and severity of adverse reactions; | — |
Countries
China
Contacts
Public ContactDa Jiang
The Fourth Hospital of Hebei Medical University
Outcome results
None listed