NCT05245760

ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zhonglin Hao · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the effects of chemoradiation and Tislelizumab on Esophageal/EGJ Cancer before and after surgery.

Detailed description

Esophageal cancer patients in this trial will receive chemoradiation therapy with tislelizumab, which is an anti-PD-1 antibody, before surgery. Patient will be evaluated for complete pathological response or major pathological response rate following chemoradiation. Patient will continue on to get tislelizumab after surgery to complete total of a year of treatment. They will be evaluated for PFS and OS. Throughout the study, drug tolerability and toxicities will be monitored.

Conditions

• Esophageal Cancer
• Esophagogastric Junction Cancer

Interventions

Type	Name	Description
DRUG	Intravenous Tislelizumab	Participants will receive 200mg, every three weeks for up to 51 weeks
DRUG	Chemotherapy	Carboplatin (AUC2) and Paclitaxel (50mg/m2), Weekly x 5 weeks
RADIATION	Fractionated radiation	Concurrent with chemo, x5 weeks
PROCEDURE	Esophagectomy	Surgical resection of cancer after chemoradiation therapy when no disease progression found.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-03-01
• Completion: 2033-12-01
• First posted: 2022-02-18
• Last updated: 2022-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study