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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031230630

Registered date:14/02/2024

Phase2 study of mFOLFOX6 plus nivolumab for patients with ESCC

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEsophageal Cancer
Date of first enrollment20/02/2024
Target sample size33
Countries of recruitment
Study typeInterventional
Intervention(s)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):Day1400 mg/m2 Fluorouracil(continuous intravenous infusion):Day1-32400 mg/m2

Outcome(s)

Primary OutcomeObjective Response Rate
Secondary OutcomeOverall survival:OS,Progression-free survival:PFS,Disease control rate:DCR,Duration of response:DoR,Advese event

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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
Exclude 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).

Related Information

Contact

Public contact
Name Yohei Kubota
Address 2-16-1,Sugao,Miyamae-ku,Kawasaki,Kanagawa Kanagawa Japan 216-8511
Telephone +81-44-977-8111
E-mail ykubota@marianna-u.ac.jp
Affiliation St. Marianna University Hospital
Scientific contact
Name Yohei Kubota
Address 2-16-1,Sugao,Miyamae-ku,Kawasaki,Kanagawa Kanagawa Japan 216-8511
Telephone +81-44-977-8111
E-mail ykubota@marianna-u.ac.jp
Affiliation St. Marianna University Hospital