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

Summary

The purpose of this study was to evaluate the safety, feasibility and outcome of anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy for locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) patient.

Conditions

• Esophageal Squamous Cell Carcinoma Stage II
• Esophageal 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)

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• The First People's Hospital of Changzhou

  collaborator OTHER

• Zhongshan Hospital (Xiamen), Fudan University

  collaborator OTHER

• Xuhui Central Hospital, Shanghai

  collaborator OTHER

• Shanghai Minhang Central Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Shanghai Fifth People's Hospital

  collaborator UNKNOWN

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Lijie Tan, MD · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-02

Primary Completion

2024-07-31

Completion

2027-07-31

Countries

• China

Study Locations