esophageal cancer unreseactable or metastatic esophageal cancer
Conditions
Interventions
Sponsors
Hiroshi Miyata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Thoracic esophageal cancer histologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma 2. Untreated unresectable advanced esophageal cancer (cT4bN0-3M0-1 or cT1-3N0-3M1, UICC-TNM classification 8th edition) However, Prior perioperative treatment or definitive chemotherapy/radiotherapy/chemoradiotherapy is acceptable if completed before enrollment. However, after completion of therapy, a recurrence-free period of 24 weeks is required for chemotherapy/chemoradiotherapy and 48 weeks for immunotherapy. Endoscopic resection with curative resection (pT1a, ly0, v0) is acceptable as a complete treatment. 3. Patients who are between 20 and 75 years old on the date of registration 4. EOCG Performance Status (PS) 0-1 5. Have one or more measurable lesions based on RECISTver1.1 6. Test values within 14 days before registration
Exclusion criteria
Exclusion criteria: 1. Having multiple cancers (registration is possible if esophageal cancer determines the prognosis) 2. Have an active systemic infection 3. You have an active autoimmune disease. However, registration is permitted if you have type I diabetes, a disease that requires only hormone replacement, or a skin disease that does not require systemic treatment. 4. Treatment with systemic corticosteroids (equivalent to prednisone exceeding 10 mg/day; administration of inhaled and topical steroids, and hormone replacement therapy are permissible) or other immunosuppressants (adverse effects for adverse events are permissible). be 5. History of interstitial lung disease or complications 6. Severe cardiac dysfunction 7. The patient does not intend to use contraception or is a pregnant or breastfeeding woman. 8. Patients judged to be unsuitable by the person in charge of this clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR; Disease Control Rate PFS; Progression-Free Survival OS; Overall Survival DoR; Duration of Response Conversion surgery irAE | — |
Contacts
Public ContactTakahito Sugase
Osaka international cancer institute
Outcome results
None listed