Esophageal carcinoma
Conditions
Interventions
Group A:Inductive chemotherapy, chemoradiation, and 2 cycles of consolidion chemotherapy
Group B:Inductive chemotherapy, chemoradiation, and 4 cycles of consolidion chemotherapy
Group C:Inductive chemotherapy, chemoradiation, and 6 cycles of consolidion chemotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Signed the informed consent prior to any trial-related procedures; 2. Male or female, age >= 18 year-old, = 6 months; 9. Have adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases diagnosed within 5 years prior to the first administration (excluding radically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); 2. Current participation in interventional clinical research treatment, or receipt of other investigational drugs or treatment with investigational devices within 4 weeks before the first administration; 3. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies); 4. Pregnant or lactating women; 5. Presence of any severe or uncontrollable systemic diseases, including but not limited to: 1) Significant, severe and refractory abnormalities in rhythm, conduction or morphology on resting electrocardiogram (ECG), such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, and chronic heart failure with New York Heart Association (NYHA) functional classification >= Grade 2; 3) Any arterial thrombosis, embolism or ischemic events within 6 months prior to study enrollment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, etc.; 4) Poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 5) History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or currently clinically active interstitial lung disease; 6) Significant and poorly controlled symptomatic abnormalities in rhythm, conduction or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia or atrial fibrillation; 7) Unstable angina pectoris, congestive heart failure, and chronic heart failure with New York Heart Association (NYHA) functional class >= Grade 2; 8) Any arterial thrombosis, embolism or ischemic events within 6 months prior to study enrollment, including but not limited to myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; 9) Poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 10) A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose, or clinically active interstitial lung disease at present; 11) Active pulmonary tuberculosis; 12) Active or uncontrolled infections requiring systemic treatment; 13) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 14) Hepatic diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 15) Poorly controlled diabetes (fasting blood glucose, FBG >10 mmol/L); 16) Urinalysis indicating urinary protein >= ++, with confirmed 24-hour urinary protein quantification >1.0 g; 6. Subjects with mental disorders who are unable to cooperate with treatment; 7. Any medical history, disease evidence, ongoing treatment or abnormal laboratory parameters that may interfere with trial results or prevent the subject from completing the entire study; or other conditions deemed ineligible for enrollment by the investigator, or other potential risks judged by the investigator to make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Organ Preservation Rate;Disease Control Rate;Disease-Free Survival;Overall Survival;Safety ; | — |
Countries
China
Contacts
Public ContactXiangbo Wan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed