MedTrace Logo

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

NCT03914443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Nivolumab

240 mg or 360 mg

DRUG

5-FU

750 or 800 mg\^2

DRUG

CDDP

70 or 80 mg/m\^2

DRUG

DTX

70 mg/m\^2

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Fiverings Co., Ltd.

    collaborator OTHER

  • National Cancer Center, Japan

    lead OTHER_GOV

Principal Investigators

  • Ken Kato, MD/PhD · Department of Gastrointestinal Medical Oncology, National cancer center hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914443 on ClinicalTrials.gov