JPRN-jRCT2031180172
Active, not recruiting
Phase 1
A feasibility trial of nivolumab with neoadjuvant CF or DCF, FLOT therapy for locally advanced esophageal carcinoma - FRONTiER
Kato Ken0 sites36 target enrollmentMarch 1, 2019
ConditionsThoracic esophageal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Thoracic esophageal cancer
- Sponsor
- Kato Ken
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenosquamous carcinoma or basal cell carcinoma
- •2\) All esophageal cancer lesions are localized in the thoracic esophagus
- •3\) Patients are classified as clinical stage T1N1\-3M0 or T2\-3N0\-3M0 in the UICC\-TNM classification 8th edition
- •4\) The age is over 18 years old and under 75 on the enrollment date
- •5\) PS 0\-1
- •6\) With or without measurable lesions
- •7\) Patients who have no medical history of treatment for esophageal cancer
- •8\) Patients who have no medical history of chemotherapy, radiotherapy and endocrine therapy including treatment for other types of cancer
- •9\) The results of laboratory tests within 14 days before enrollment meet the inclusion criteria
- •10\) Esophageal cancer radical surgery (R0\) by open\-chest surgery (or thoracoscopic surgery) and laparotomy (or laparoscopic surgery) is judged possible
Exclusion Criteria
- •1\) Patients who have active multiple cancers
- •2\) Patients who have infectious disease which is active and need the systemic treatment
- •3\) Positive with HBs antigen, or HCV\-RNA or anti HIV antibody, or anti HTLV\-1 antibody tests
- •4\) Negative with HBs antigen test and positive with anti HBs antibody or anti HBc antibody tests, and positive with HBV\-DNA quantitative test
- •5\) Pregnant, suspected pregnant or lactating
- •6\) Patients who have Psycosis or psychiatric symptoms are judged inappropriate for paticipation of the trial
- •7\) Patients who need the treatment with continued use of flucytosine, phenytoin or warfalin pottasium
- •8\) Patients who have a medical history of allergy to iodine
- •9\) Patients who have hypersensitivity to docetaxel, cisplatin, oxaliplatin, and drug containing polysorbate 80
- •10\) Patients who have a complication or a history of highly sensitive reactions to antibody formulations
Outcomes
Primary Outcomes
Not specified
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