Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2027

Conditions
Esophageal Squamous Cell Carcinoma Stage IIEsophageal Squamous Cell Carcinoma Stage III
Interventions
PROCEDURE

Neoadjuvant Chemoradiotherapy

"Chemotherapy: carboplatin (AUC 2 mg/mL per min) and paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. For each cycle, Carboplatin and paclitaxel were administered 30 minutes apart.~Radiotherapy: A total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy, 5 days per week (Radiotherapy was performed on the 2nd, 3rd, 4th, 5th, and 6th day in each cycle, and only 3 times in the 5th cycle)"

DRUG

Tislelizumab

"Tislelizumab (200mg/time) was administered intravenously on the 1st and 22nd day.~The intravenous injection lasts about 30 minutes (micropump is recommended, intravenous bolus is prohibited, duration should be not less than 20 minutes and not more than 60 minutes);"

PROCEDURE

Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)

After neoadjuvant therapy, patients in groups receive Ivor-Lewis or Mckeown Esophagectomy (Mckeown Esophagectomy recommended)

Trial Locations (1)

200032

RECRUITING

Shanghai Zhongshan Hospital, Shanghai

All Listed Sponsors
collaborator

Peking University Cancer Hospital & Institute

OTHER

collaborator

Shanghai Chest Hospital

OTHER

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

collaborator

The First People's Hospital of Changzhou

OTHER

collaborator

Zhongshan Hospital (Xiamen), Fudan University

OTHER

collaborator

Xuhui Central Hospital, Shanghai

OTHER

collaborator

Shanghai Minhang Central Hospital

OTHER

collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

collaborator

Zhejiang Cancer Hospital

OTHER

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Sun Yat-sen University

OTHER

collaborator

Shanghai Fifth People's Hospital

UNKNOWN

lead

Shanghai Zhongshan Hospital

OTHER