Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
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.
| Status | Recruiting |
| Enrollment | 18 |
| Est. completion date | July 31, 2024 |
| Est. primary completion date | January 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Sun yat-sen University Cancer Center | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerated fraction dose | Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy. | 6 months | |
| Secondary | 2-year overall survival rate | 2-year | ||
| Secondary | 2-year progression-free survival rate | 2-year | ||
| Secondary | Clinical response rate | The percentage of patients who had partial remission or complete remission after therapy | 2 months after radiotherapy | |
| Secondary | The rate of grade 3 or 4 toxicities according to CTCAE5.0 | the percentage of patients who develop grade 3 or 4 toxicities | 1 year after therapy |
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