drugset / Trial / NCT06020885

Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.

NCT06020885

Phase 1 Active not recruiting 18 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.

Timeline

Start
2023-08-31
Primary completion
2025-10-30
Completion
2025-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cisplatin Other / unclassified 60 mg/m2
Subject Paclitaxel Small molecule 260 mg/m2
Subject Toripalimab Monoclonal antibody 240 mg