This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase. The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.
Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy. Those without disease progression then get definitive radiotherapy with immune maintenance therapy for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
immunotherapy, 200 mg on day 1 per 3 weeks
chemotherapy, 175 mg/m² on day 1 per 3 weeks
chemotherapy, AUC=5 on day 1 per 3 weeks
Patients without disease progression after four cycles of chemoimmunotherapy receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy delivered over 28 fractions.
Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, Shanghai Municipality, China
RECRUITING1-year progression-free survival
From the initial administration of the study drug to the first identification of disease progression or mortality, whichever happens first. In the case of patients who had not encountered local control failure or death, specifically in terms of progression-free survival, the time of the last tumor assessment was considered as the endpoint. Tumor response was evaluated by investigators following RECIST v1.1 criteria.
Time frame: 1 year
Acute toxicity
Monitor the occurrence of acute toxic reactions (based on CTCAE4.03) and subacute toxic reactions (RTOG) in the treatment of cN3 ESCC with the combination of chemotherapy, immunotherapy, and ongoing radiotherapy, both during the treatment course and within three months after its completion.
Time frame: 3 months
Quality of Life (QoL)
Collect QoL data on cN3 ESCC patients. The data is measured by EORTC QLQ-C30 (Version 3.0) according to investigator collection at the starting and ending time of the treatment. EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The core and disease-specific for ESCC modules are selected to estimate treatment related influence on patients' life. The final score of the questionnaire is collected and analyzed according to detailed scoring procedures from manuals.
Time frame: 1 years
Objective response rate
Defined as the proportion of patients with complete response (CR) or partial response (PR)
Time frame: 1 year
Duration of response
Defined as the period from the recognition of an objective response to the first identification of either progression or death, whichever event transpired first.
Time frame: 1 year
Disease control rate
Defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD)
Time frame: 1 year
Immune Progression Free Survival
defined as the duration from the initial dose of tislelizumab to the first identification of either disease progression or death, whichever happens first. Tumor response was evaluated by investigators following iRECIST criteria.
Time frame: 1 year
Overall survival
defined as the period from the initial drug administration to the subject's demise from various causes. In cases where patients were lost to follow-up prior to their passing, the date of their last documented contact was documented. For patients still alive at the last analyzed time point, the time of their last contact was considered as their survival duration. In the analysis of survival and subsequent treatment, all patients were monitored until their death, loss to follow-up, or the conclusion of the study.
Time frame: 1 year
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