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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split-course hypo-CCRT | Radiation | Split-course hypo-CCRT is administered at the following three dose levels:
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerated fraction dose | Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival rate | 2-year | |
| 2-year progression-free survival rate | 2-year | |
| Clinical response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Professor | Sun yat-sen universtiy cancer center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42028290 | Derived | Liu F, Wang D, Luo G, Zhang H, Liu Y, Zhang P, Xia B, SiTu Y, Wang M, Zhang D, Hu Y, Wang J, Qiu B, Liu H. Fraction dose escalation of split-course concurrent chemoradiotherapy following induction chemo-immunotherapy in unresectable locally advanced oesophageal squamous carcinoma in China (GASTO-10102): a single-centre phase 1 study. EClinicalMedicine. 2026 Apr 17;95:103893. doi: 10.1016/j.eclinm.2026.103893. eCollection 2026 May. |
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| Induction chemo-immunotherapy | Drug | All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1. |
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| Concurrent chemotherapy | Drug | Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with 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 | the percentage of patients who develop grade 3 or 4 toxicities | 1 year after therapy |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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