A Phase 1 interventional study of Nivolumab and 5-FU in Locally Advanced Esophageal Squamous Cell Carcinoma, sponsored by National Cancer Center, Japan. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by National Cancer Center, Japan · Phase 1, Interventional, and Treatment
The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.
657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.
This study's enrollment of 37 is below the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →National Cancer Center, Japan is the lead sponsor of 18 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Biological: Nivolumab · Drug: 5-FU · Drug: CDDP
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
Biological: Nivolumab · Drug: 5-FU · Drug: CDDP
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Biological: Nivolumab · Drug: 5-FU · Drug: CDDP · Drug: DTX
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m\^2, every 3 week CDDP: 70 mg/m\^2, every 3 week DTX: 70mg/m\^2, every 3 weeks"
Biological: Nivolumab · Drug: 5-FU · Drug: CDDP · Drug: DTX
Rate of participants with dose limiting toxicities (DLTs)
To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from initial dose to 30 post-operative days
Response rate (RR): percentage of participants with with a best response of CR or PR
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from baseline to date of disease progression, approximately 24 months
Pathological complete response rate
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from baseline to operation, average of 10 weeks after initial dose
Radical resection rate
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: at operation, average of 10 weeks after initial dose
Treatment completion rate
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from baseline to operation, average of 10 weeks after initial dose
Adverse event (AE) expression rate
To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: up to 30 postoperative days
Progression-free survival (PFS)
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from baseline to date of disease progression or death, approximately 24 month
Overall survival (OS)
To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx
Time frame: from baseline to date of death, approximately 24 month
Plan to share: Undecided
Ran from May 2019 to primary completion in Mar 2025, 70 months.
Of 40 phase 1 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 70. This study's 70 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Esophageal Squamous Cell Carcinoma →
National Cancer Center, Japan