Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Split-course hypofractionated concurrent chemoradiotherapy, Fraction dose escalation, Induction chemo-immunotherapy, Unresectable locally advanced esophageal squamous carcinoma
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 of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.
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.
Interventions
RADIATIONSplit-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.
All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
DRUGConcurrent chemotherapy
Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerated fraction dose | 6 months | Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year overall survival rate | 2-year | — |
| 2-year progression-free survival rate | 2-year | — |
| Clinical response rate | 2 months after radiotherapy | The percentage of patients who had partial remission or complete remission after therapy |
| The rate of grade 3 or 4 toxicities according to CTCAE5.0 | 1 year after therapy | the percentage of patients who develop grade 3 or 4 toxicities |
Countries
China
Outcome results
None listed