At a glance

ClinicalIndex Comparison Record

Phase 1Active· 18 target

Drug / intervention

Induction chemo-immunotherapy +2 moredrug

Likely dose

Induction chemo-immunotherapy 260mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06020885

NCT06020885Phase 1ActiveUpdate OverdueUpdated 11mo ago · Completion was 8mo ago

Enrollment Stalled

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

Sun Yat-sen University·interventional·Posted Sep 1, 2023·Updated Jul 21, 2025

In Brief

A Phase 1 clinical trial evaluating Split-course hypo-CCRT, Induction chemo-immunotherapy, and 1 other intervention for Esophageal Squamous Cell Carcinoma. Active but no longer recruiting, targeting 18 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEsophageal Squamous Cell Carcinoma

CountriesChina

Collaborators--

Timeline

Phase 1ActiveOverdue

202420252026

Enrollment StartAug 2023

First PostedSep 2023

Primary CompletionOct 2025

TodayJul 2026

First PostedSep 1, 2023

Enrollment StartAug 31, 2023

Primary CompletionOct 30, 2025

TodayJul 1, 2026

Enrollment to primary: 2.2 yearsPosted 2.8 years ago

Interventions

Split-course hypo-CCRTradiation

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.

Induction chemo-immunotherapydrug

All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.

Concurrent chemotherapydrug

Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.