Status:
ACTIVE_NOT_RECRUITING
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Lead Sponsor:
Sun Yat-sen University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06020885
Start Date
August 31 2023
End Date
October 30 2025
Last Update
July 21 2025
Active Locations (1)
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1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060