Active — Not RecruitingPhase 1

Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.

China18 participantsStarted 2023-08-31

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Tolerated fraction dose

Timeframe: 6 months

Trial details

NCT IDNCT06020885

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

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