Esophageal squamous cell carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Esophageal squamous cell carcinoma confirmed by histology (stage IIA-IVA of the neck and upper thoracic segment; IIB-IVA of the middle and lower segment contains supraclavicular lymph node metastasis); 2. Have measurable tumor lesions (spiral CT scan >= 10mm, meet RECIST 1.1 standard); 3. Expected survival time> 3 months; 4. Aged >= 18 years old, no gender limit; 5. ECOG PS: 0-2 points; 6. The functions of important organs meet the following requirements: a) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 9g/dL; b) Bilirubin 60 mL/min; 7. Women of childbearing age must take a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use it uninterruptedly during the treatment period and 6 months after the last therapeutic dose. Contraceptive measures 8. The patient voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffer from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. The patient has a history of radiotherapy; 3. The patient has perforated esophagus; 4. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 5. People with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected; 7. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 8. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 9. A history of psychotropic drug abuse, alcohol or drug abuse; 10. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 11. The researcher thinks it is inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Affiliated Cancer Hospital of Harbin Medical University