Serplulimab Combined with Chemotherapy in Patients with Resectable Esophageal Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

October 31, 2024

Study Completion Date

December 31, 2029

Conditions
Esophageal Squamous Cell CarcinomaNeoadjuvant Therapy
Interventions
COMBINATION_PRODUCT

Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy

Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days.

PROCEDURE

Esophagectomy

"Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy.~The surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon."

OTHER

sample

"Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use.~5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery.~Tumour sample will be collected before neoadjuvant therapy and after surgery."

Trial Locations (1)

310009

2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER