Phase2 study of mFOLFOX6 plus nivolumab for patients with ESCC
- Conditions
- Esophageal Cancer
- Registration Number
- JPRN-jRCTs031230630
- Lead Sponsor
- Kubota Yohei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
(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
(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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method