Esophageal cancer
Conditions
Interventions
Research group:toripalimab 240mg iv, Q3W, 4cycles
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Thoracic esophageal squamous cell carcinoma diagnosed by cytology or histology; 2. Patients with thoracic esophageal squamous cell carcinoma who have not received any anti-tumor treatment and have no surgical contraindication by MDT consultation; 3. Patients who agreed to receive neoadjuvant radiotherapy and toripalimab injection treatment + surgery + postoperative follow-up treatment mode; 4. Consent to collect tissue and blood samples needed for research and apply them to related research; 5. At least one measurable lesion; 6. Age >= 18 years old and < 75 years old; 7.ECOG score 0-1; 8. Able to understand and provide written informed consent, and able to comply with the treatment, follow-up and related procedures specified in the study protocol.
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 |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response;Disease free survival;Overall survival;TRAEs; | — |
Countries
China
Contacts
Public ContactBaosheng Li
Shandong Cancer Hospital
Outcome results
None listed