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 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Phase 1

Started

2023-08-31

Last updated

2025-07-21

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Split-course hypo-CCRTInduction chemo-immunotherapyConcurrent chemotherapy

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.

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * histologically confirmed ESCC * II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002) * Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 * Charlson Comorbidity Index score≤4 * oral medication can be administered despite esophageal obstruction * adequate hematological, renal and hepatic functions Exclusion Criteria: * contraindication for radiotherapy or chemotherapy * prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ * distant metastasis, except for celiac or supraclavicular lymph nodes metastases

Primary outcome measure(s)

Tolerated fraction dose — 6 months
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.

Trial sites (1)

Facility	City	Region	Status
Sun yat-sen University Cancer Center	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06020885 on ClinicalTrials.gov ↗ ← All trials in China