Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group: induction immunotherapy plus chemotherapy followed by definitive chemoradiotherapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent, have good compliance, and cooperate with follow-up; 2, age =18 years old and = 70 years old; 3, Histological evidence of locally advanced esophageal squamous cell carcinoma (including inoperable, contraindications to surgery, or refusal of surgery) with clinical stage T1-4N1-3M0 or T2-4N0M0 ) or exhibites M1 disease limited to supraclavicular lymph node metastases only (AJCC 8 th); 4, The patient has at least one measurable or unmeasurable lesion according to RECIST 1.1 criteria; 5. Did not receive any anti-tumor therapy before enrollment; 6, ECOG score 0~1 points; 7. Expected survival =3 months; 8, The main organ function is normal, that is, meet the following standards (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct) : Hemoglobin (Hb) = 90 g/L; Neutrophil count (ANC) = 1.5 × 109/L; Platelet count (PLT) = 100 ×109/L; Total bilirubin (TBIL) = 1.5 upper limit of normal (ULN); ALT and AST = 2.5 ULN; Serum creatinine (Cr) = 1.5 ULN or endogenous creatinine clearance = 60ml/min (Cockcroft-Gault formula); International standardized ratio (INR) =1.5×ULN and activated partial thromboplastin time =1.5×ULN;
Exclusion criteria
Exclusion criteria: 1. Allergic to therapeutic drugs; 2. Patients with high risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation; 3. Poor nutritional status; 4. Surgical operations (except biopsy) were performed within 28 days prior to inclusion in this study; 5. The presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. Patients have received or is receiving following treatment: a. chemotherapy, radiation, immunotherapy, or targeted therapy; b. received any other experimental drug treatment or participated in other interventional studies within 4 weeks before signing the informed consent; c. patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks before enrollment; d. have received or plan to receive live attenuated vaccine within 4 weeks before the first dose;; 7. Patients with active autoimmune disease or a history of the following, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, nephritis, etc.) shall not be included. Exceptions include: patients with a history of autoimmune hypothyroidism who receive thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar is under control after treatment with an insulin administration regimen may participate in this study. 8. Patients with immune deficiency. HIV-positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, allogeneic hematopoietic stem cell transplantation were not included.; 9. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, congestive heart failure New York Heart Association (NYHA) Grade = 2; 10. Active or uncontrolled severe infection (>CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia before first administration; 11. Patients with pulmonary fibrosis, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe lung function impairment; 12. Active tuberculosis infection; 13. Active hepatitis; 14. Abnormal laboratory values of sodium, potassium, and calcium greater than grade 1 were present in the 2 weeks prior to randomization and did not improve after treatment; 15. Pregnant (positive pregnancy test before medication) or breastfeeding women; 16. Patients have had or co-developed other malignancies requiring active treatment (with the exception of those who have been adequately treated, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ); 17. Patients deemed unsuitable for enrollment according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Local-regional progression-free survival;Distant metastasis-free survival; | — |
Countries
China
Contacts
Public ContactHong Ge; Chengcheng Fan
Henan Cancer Hospital
Outcome results
None listed