drugset / Trial / NCT07618910

Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC

NCT07618910

Phase 2 Not yet recruiting 33 enrolled Tang-Du Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC). The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.

Timeline

Start
2026-05-30
Primary completion
2027-05-30
Completion
2028-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 130 mg/m2 Intravenous
Subject Retlirafusp alfa Protein / enzyme biologic 1800 mg Intravenous