A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma

Sponsor
National Cancer Center, Japan
Study ID
NCT03914443
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    240 mg or 360 mg
  • 5-FU — DRUG
    750 or 800 mg\^2
  • CDDP — DRUG
    70 or 80 mg/m\^2
  • DTX — DRUG
    70 mg/m\^2

Study Details

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.

Key Dates

Start date
May 7, 2019
Status verified
May 2025
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
37 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    "Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m\^2, every 3 week CDDP: 80 mg/m\^2, every 3 week "
  • Experimental: Cohort B
    "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 "
  • Experimental: Cohort C
    "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"
  • Experimental: Cohort D
    "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"

Primary Outcome Measure

Rate of participants with dose limiting toxicities (DLTs) [ Time Frame: from initial dose to 30 post-operative days ]