esophageal cancer
Conditions
Interventions
case series:toripalimab 240mg iv, Q3W, 4cycles
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically/cytologically confirmed esophageal squamous cell Cancer; 2. Agree to follow the study protocol and follow up procedures; 3. Agree to have histologic tumor and blood sample collected; 4. The patient must have a measurable lesion; 5. Adults no younger than 18 years and less than 70 years; 6. ECOG score for physical condition is 0 ~ 1; 7. Blood routine examination: absolute neutrophil count (ANC) =1.5 x 10^9/L, platelets =100 x 10^9/L hemoglobin = 9 g/dL; 8. Liver function: total bilirubin =1.5 times the upper limit of normal (ULN); alanine transaminase (ALT), and aspartate aminotransferase (AST) =2.5 times ULN; Serum albumin 28g/dL; 9. Renal function: creatinine clearance =40 mL/min ; 10. Written informed consent form being signed. Agree to follow the study protocol and follow up procedures.
Exclusion criteria
Exclusion criteria: 1. Any systemic anticancer therapy for EC, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine therapy; 2. Use of immuno-inhibitory drugs within 4 weeks of initial treatment, not including nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids; 3. Active, known, or suspected autoimmune diseases. (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc.; (vitiligo, diabetes, need hormone replacement therapy caused by autoimmune thyroiditis JiaJian, and other autoimmune disease patients without recurrence can be incorporated into); 4. Known allogeneic organ transplantation (excluding cornea) or allogeneic hematopoietic stem cell transplantation; 5. Allergic to monoclonal antibodies; 6. Any unstable systemic disease (including active infection, out of control of high blood pressure, unstable angina, angina onset within the past 3 months, congestive heart failure (or greater New York heart association (NYHA) class II), all infarction (group into the first 6 months), need drug therapy of severe arrhythmia, liver, kidney or metabolic disease; 7. Patients with other cancer; 8. Unresectable esophageal squamous cell Cancer after neoadjuvant treatment of radiotherapy and toripalimab; 9. Patients considered unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treat-related adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| the initial tumor response;Major Pathologic Response;disease free survival of 1 year;disease free survival of 2 year; | — |
Countries
China
Contacts
Public ContactBaosheng Li
Outcome results
None listed