Thoracic esophageal cancer Thoracic esophageal cancer, Immune-checkpoint inhibitor (ICI)
Conditions
Interventions
For the administration of immune checkpoint inhibitors to postoperative patients with esophageal cancer, nivolumab is administered at a dose of 480 mg intravenously every 4 weeks. Duration of treatmen
Sponsors
Goto Hironobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible 1.Primary tumor is located in the thoracic esophagus and is histologically diagnosed as squamous cell carcinoma by endoscopic biopsy. 2.Patient underwent radical resection after preoperative DCF therapy without pathologic complete response. 3.Patients must be at least 18 years of age on the date of enrollment. 4.Gender is irrelevant. 5.PS is 0 or 1 by ECOG criteria. 6.Patients can be enrolled between 4-16 weeks (28-112 days postoperatively) after complete resection. 7.Patients must be confirmed disease-free by thoracoabdominal CT within 4 weeks prior to enrollment. 8.The latest laboratory values within 14 days prior to enrollment (the same day of the week 2 weeks prior to enrollment is acceptable) meet all of the following 9.The patient has given his/her free and voluntary written consent to participate in this clinical research.
Exclusion criteria
Exclusion criteria: Patients with any one of the following will be excluded 1) Have an active systemic infection. 2) Have an active autoimmune disease. 3) Requires treatment with systemic corticosteroids (prednisone equivalent >10 mg/day; inhaled and topical steroids and hormone replacement therapy are acceptable) or other immunosuppressive agents (use for adverse events is acceptable). 4) Currently or previously receiving treatment with immune checkpoint inhibitors. 5) History of interstitial lung disease or extensive findings of these on CT. 6) Other patients deemed inappropriate by the investigators of this clinical study. 7) Unwilling contraceptive patients and pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, distant metastases free survival, percentage of adverse events | — |
Contacts
Public ContactHironobu Goto
Kobe University Hospital
Outcome results
None listed