Neo-NTP-CRT for Locally Advanced ESCC

Sponsor
National Taiwan University Hospital
Study ID
NCT05130684
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    adding nivolumab to conventional neoadjuvant CRT

Study Details

The investigators hypothesize that nivolumab combined with neoadjuvant chemoradiotherapy (CRT) is safe and effective in patients with locally advanced esophageal squamous cell carcinoma (LAESCC).

Key Dates

Start date
Feb 22, 2021
Status verified
Apr 2021
Primary completion
Mar 1, 2023
Completion
Mar 1, 2024

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neo-CRT
    * Nivolumab 240 mg, 30-min IVF, Q2W on days -14, 1, 15, and 29; * Paclitaxel 50 mg/m2, 1h-IVF, on days 1, 8, 15, 22, and 29; * Cisplatin 30 mg/m2,1h-IVF,on days 1, 8,15, 22, and 29; * RT: 1.8 Gy/fraction, 5 days a week, for 25 fractions (total dose= 45 Gy).

Primary Outcome Measure

change in treatment related death [ Time Frame: 30 days ]

Central Contacts