PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

PHASE3RecruitingINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

January 1, 2031

Study Completion Date

January 31, 2031

Conditions
Squamous Cell Esophageal CarcinomaEsophageal CancerOesophageal Cancer
Interventions
DRUG

Sintilimab

Sintilimab 200mg, IV (in the vein) on day 1 and day 22

RADIATION

Preoperative radiotherapy

External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

DRUG

Paclitaxel

50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

DRUG

Cisplatin

25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

PROCEDURE

esophagectomy

McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

Affiliated Cancer Hospital of Shantou University Medical College

OTHER

lead

Sun Yat-sen University

OTHER