NCT05043688

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (estimated)
• Sponsor: Zhigang Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.

Detailed description

This study aimed to evaluate the efficacy and safety of adding immunotherapy to neoadjuvant chemotherapy (CT) or chemoradiotherapy (CRT) compared to neoadjuvant CRT alone for resectable locally advanced esophageal squamous cell carcinoma (ESCC)

Conditions

• Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
RADIATION	radiotherapy	The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

Timeline

• Start date: 2021-09-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2021-09-14
• Last updated: 2024-10-17

Locations

5 sites across 1 country: China