NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 30, 2024

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2029

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
RADIATION

Neoadjuvant Chemoradiotherapy

"Neoadjuvant chemoradiotherapy:~1. Radiation dose: 1.8Gy/Fx, DT41.4Gy/23Fx.~2. Concurrent chemotherapy: Albumin-bound paclitaxel 60mg/m² + Cisplatin 25mg/m² on D1, D8, D15, D22, D29."

DRUG

neoadjuvant immunotherapy

Begins on the second day after the completion of concurrent chemoradiotherapy, and no later than one week. Toripalimab 240mg Q3W, for a total of two cycles.

PROCEDURE

Surgery

Preoperative assessment is conducted 3 weeks after the last neoadjuvant immunotherapy, and surgery is performed within 4-6 weeks. All patients undergo minimally invasive radical esophagectomy, either McKeown or Ivor-Lewis, with extended two-field or three-field lymph node dissection.

DRUG

adjuvant immunotherapy

Whether to undergo postoperative adjuvant immunotherapy is determined based on the pathological response. Patients with pCR are only observed without receiving adjuvant treatment, while those not reaching pCR receive one year of adjuvant Toripalimab.

Trial Locations (1)

200127

Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER

NCT06762158 - NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC | Biotech Hunter | Biotech Hunter