esophageal cancer
Conditions
Interventions
None listed
Sponsors
Kansai Rosai Hospital
Osaka University Gastroenterological Surgery, Osaka International Cancer Center, Kinki University Surgery, Osaka Illness Center Surgery, Osaka Acute Disease Center Surgery, Sakai Municipal Medical Center Surgery, Kindai Nara Hospital Surgery, Kansai Medical University Hospital Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The primary tumor is located at either the cervical, thoracic esophagus, or esophagogastric junction (UICC-TMN 8th edition). Histopathologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, basaloid carcinoma, or adenocarcinoma. Planned treatment (excluding palliative treatment) for untreated esophageal cancer with distant metastasis (distant organ metastasis or distant lymph node metastasis). he presence of distant metastasis (distant organ metastasis or distant lymph node metastasis) has been confirmed by imaging (CT, MRI or PET) or histopathologically. Distant metastatic organs shall be liver/lung, bone, brain, etc., regardless of number, size, or distribution. Distant lymph nodes are regional extraneous lymph nodes, excluding supraclavicular and intramediastinal lymph nodes. Duplication of distant metastatic organs and distant lymph nodes is allowed. Examples of distant metastatic organs of esophageal cancer Liver, lung, lymph node, bone, brain, adrenal gland, skin, muscle, peritoneum, pleura, pericardium, etc. Age: 20 years old or older ALT less tahn 100 IU/L Creatinine clearance more than 40ml/min (Cockcroft-Gault formula) Patients with a prognosis of 3 months or longer Patients who have given their consent to participate in the study
Exclusion criteria
Exclusion criteria: Active multiple cancers at the start of first treatment Previous history of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other antibody therapy or drug therapy for the purpose of controlling T cells patients with History of autoimmune disease, interstitial pneumonia, history of organ transplantation, or tuberculosis Patients who are expected to undergo esophageal or tracheal stenting Patients who are judged to lack the ability to consent due to complications such as dementia Patients who are judged to be inappropriate for this study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (assessed by 3-year survival rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment content, progression-free survival, response rate, disease control rate, adverse events, safety of conversion surgery (intraoperative and postoperative complications), overall survival in R0 resection patients, progression-free survival, date of recurrence, recurrence form, pathological response | — |
Countries
Japan
Contacts
Public ContactKeijiro Sugimura
Kansai Rosai Hospital Gastroenteological Surgery
Outcome results
None listed