Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
July 18, 2025 updated by: Hui Liu, Sun Yat-sen University
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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 Type
Interventional
Enrollment (Estimated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experiment group
This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled.
Split-course hypo-CCRT is administered at the following three dose levels:
|
Split-course hypo-CCRT is administered at the following three dose levels:
All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tolerated fraction dose
Time Frame: 6 months
|
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-year progression-free survival rate
Time Frame: 2-year
|
2-year
|
|
|
2-year overall survival rate
Time Frame: 2-year
|
2-year
|
|
|
Clinical response rate
Time Frame: 2 months after radiotherapy
|
The percentage of patients who had partial remission or complete remission after therapy
|
2 months after radiotherapy
|
|
The rate of grade 3 or 4 toxicities according to CTCAE5.0
Time Frame: 1 year after therapy
|
the percentage of patients who develop grade 3 or 4 toxicities
|
1 year after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hui Liu, Professor, Sun yat-sen universtiy cancer center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2023
Primary Completion (Estimated)
October 30, 2025
Study Completion (Estimated)
October 30, 2025
Study Registration Dates
First Submitted
August 26, 2023
First Submitted That Met QC Criteria
August 26, 2023
First Posted (Actual)
September 1, 2023
Study Record Updates
Last Update Posted (Actual)
July 21, 2025
Last Update Submitted That Met QC Criteria
July 18, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Carcinoma
- Carcinoma, Squamous Cell
- Immunologic Factors
- Physiological Effects of Drugs
- Immunomodulating Agents
Other Study ID Numbers
- GASTO-10102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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