Esophageal squamous carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 year male or female; 2. The clinical stages of esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) are stage II, III and IV (according to AJCC Version 8); 3. Patients with advanced esophageal squamous cell carcinoma who had received at most one systematic treatment; 4. Patients with at least one evaluable or measurable lesions as per RECIST version 1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Survival expectation >= 3 months; 7. The function of the main organs was normal, and the blood routine, biochemical and coagulation tests were basically normal; 8. The immune index is basically normal; 9. The researchers concluded that the treatment had a survival benefit.
Exclusion criteria
Exclusion criteria: 1. Known or suspected active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); 2. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation; 3. Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 4. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction within 24 weeks; (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia; 5. Active hepatitis B (positive detection of hepatitis B virus surface antigen [HBsAg] in the screening period, and detection of HBV-DNA detection value higher than the upper limit of the normal value of the laboratory in the research center) or hepatitis C (in the screening period, hepatitis C virus surface antibody [ HCsAb] positive, HCV-RNA positive); 6. Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above; 7. Toxicity of previous antitumor therapy did not return to <= CTCAE level 1 (except for hair loss) or to the level specified in the inclusion/exclusion criteria; 8. Allergic reactions to test drugs for this application; 9. A woman who is pregnant or breastfeeding; 10. The investigator determined that the subject had other factors that might lead to the termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;security; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;objective response rate;overall survival; | — |
Countries
China
Contacts
Fujian Cancer Hospital