Esophageal Cancer Esophageal Cancer
Conditions
Interventions
mFOLFOX6 and nivolumab are administered every 2 weeks at the following dose.
nivolumab:Day1,240mg/body
Oxaliplatin:Day1,85mg/m2
Calcium Levofolinate Hydrate:Day1 200g/m2
Fluorouracil(bolus injection)
Sponsors
Kubota Yohei
Sunakawa Yu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically comfirmed squamous cell carcinoma or adenosquamous carcinoma of esophagus (including esophagogastric junction). (2) Unresectable or recurrent esophageal cancer that is not eligible for curative treatment (surgery, radiotherapy, or chemoradiotherapy). (3) No history of systemic chemotherapy as primary treatment for unresectable or recurrent esophageal cancer. (4) Age>=18 years. (5) ECOG Performance Status (PS) of 0-2. (6) At least one measurable lesion based on RECIST Ver.1.1. (7) Adequate organ function
Exclusion criteria
Exclusion criteria: (1) Patients with esophageal adenocarcinoma. (2) Presence of symptomatic central nervous system metastasis (e.g., brain metastasis or leptomeningeal dissemination). (3) Histroy of major surgery or significant trauma within at least 14 days prior to registration. (4) Histroy of previous treatment with immune checkpoint inhibitors. (5) Active known concurrent cancer (synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of less than 3 years, except for early cancers such as superficial esophageal cancer or head and neck superficial cancer where prognosis is not considered, and lesions equivalent to intramucosal carcinoma or mucosal carcinoma that is judged to be cured by local treatment are allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival:OS,Progression-free survival:PFS,Disease control rate:DCR,Duration of response:DoR,Advese event | — |
Contacts
Public ContactYohei Kubota
St. Marianna University Hospital
Outcome results
None listed