drugset / Trial / NCT05743504

Immunotherapy With CCRT Followed by Surgery for Locally Advanced ESCC Patients

NCT05743504

Phase 1/2 Unknown 32 enrolled National Taiwan University Hospital
NaSingle-groupOpen-labelTreatment

Summary

The prognosis of ESCC is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that TMT, consisted of neoadjuvant concurrent CCRT and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. As a consequence, it is mandatory to develop new pharmacotherapeutic regimen for TMT. In our previous prospective studies, we found higher levels of serum immune-related biomarkers, VEGF-A, TGF-β1, and soluble PD-L1, before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy. In the present clinical trial, we plan to investigate whether incorporation of tiragolumab (Anti-TIGIT) and atezolizumab (Anti-PD-L1) into standard TMT will be safe while improve the pathological complete response rate. By the present research, we expect to develop a new TMT regimen for this poor prognostic disease.

Timeline

Start
2023-09-18
Primary completion
2025-05-31
Completion
2025-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiragolumab Monoclonal antibody