Study of Neoadjuvant Nivolumab or Placebo Plus Chemotherapy Followed by Surgery and Adjuvant Treatment in Subjects With Resectable ESCC

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

November 1, 2022

Study Completion Date

March 1, 2024

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
DRUG

Nivolumab

Nivolumab, 360mg intravenous infusion (ivgtt.), on DAY1, Q3W for two cycles;

DRUG

Cisplatin

80 mg/m2 on DAY2 with paclitaxel, Q3W or 80 mg/m2 on DAY1, Q3W ivgtt for two cycles

DRUG

Paclitaxel

175 mg/m2 on DAY2, with cisplatin Q3W, ivgtt for two cycles

DRUG

5Fluorouracil

800 mg/m2 on DAYS1-5 with cisplatin, Q3W for two cycles

PROCEDURE

Esophagectomy (minimally invasive)

4-6 weeks after neoadjuvant therapy.

Trial Locations (1)

200032

RECRUITING

180 Fenglin Road, Shanghai

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Shanghai Zhongshan Hospital

OTHER