This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study requirements;
Age ≥ 18 years and < 75 years at the time of signing the informed consent form, regardless of gender;
Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced unresectable ESCC (medically unsuitable for surgery or refusal of surgical intervention), and suitable for cCRT, including: stages II-IVa and certain cases of stage IVb (involving only supraclavicular lymph node metastasis) (AJCC version 8 ) meeting the criteria;
Estimated life expectancy of at least 6 months;
History of other malignancies;
History of fistula caused by primary tumor infiltration;
Patients at high risk of esophageal fistula or with signs of esophageal perforation;
History of esophageal cancer surgery;
Parallel
Camrelizumab
Biological/VaccineThis study aims to compare the efficacy and safety of two novel treatment strategies-short-course definitive chemoradiotherapy combined with adjuvant camrelizumab, and short-course definitive chemoradiotherapy combined with concurrent plus adjuvant camrelizumab-in patients with locally advanced unresectable esophageal squamous cell carcinoma.
1-year Progression- Free Survival
1-year progression-free survival (PFS) defined as the probability from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
complete response rate
Complete response rate at 3 months after completion of radiotherapy: assessed by CT, high-resolution MRI and/or PET-CT, in combination with endoscopic ultrasound-guided bite-on-bite biopsy.
treatment-related adverse events
Grade ≥3 treatment-related adverse events will be recorded according to CTCAE version 5.0 during the treatment period, from study enrollment until 90 days after the final administration of chemoradiotherapy.
Overall Survival
Defined as from date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 100 months
Duration of Response
From the time of first response to disease progression or death from any cause, whichever came first, assessed up to 100 months
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Ning Jiang, M.D./Ph.D.
Lead sponsor
Jiangsu Cancer Institute & Hospital
Sponsor institution
