Trials / Active Not Recruiting

Active Not RecruitingNCT06020885

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 18 (estimated)

Sponsor: Sun Yat-sen University · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

Detailed description

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Split-course hypo-CCRT	Split-course hypo-CCRT is administered at the following three dose levels: * Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course; * Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course; * Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
DRUG	Induction chemo-immunotherapy	All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
DRUG	Concurrent chemotherapy	Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.

Timeline

Start date: 2023-08-31
Primary completion: 2025-10-30
Completion: 2025-10-30
First posted: 2023-09-01
Last updated: 2025-07-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06020885. Inclusion in this directory is not an endorsement.