A Study of Adebrelimab Combined With Chemoradiotherapy in the Treatment of Esophageal Small Cell Carcinoma
NCT Number: NCT06478264
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Small Cell Carcinoma
Interventions: DRUG: Etoposide|DRUG: Cisplatin|DRUG: Carboplatin|DRUG: Adebrelimab|RADIATION: radiotherapy
Sponsor: Zhangzhou Municipal Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-13
Completion Date: 2027-07-13

Summary:
To evaluate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of esophageal small cell carcinoma

Primary Outcome Measures: Objective response rate (ORR), Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation., 1 year
Secondary Outcome Measures: Disease control rate (DCR), Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria., 1 year|Progression-free survival (PFS), PFS was defined as the date from which the subject was first given medication to the date when tumor progression (as assessed by the criteria, with or without continued treatment) was first recorded or the date of death from any cause, whichever came first., 1 year|Overall survival (OS), Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring., 2 years|One-Year Overall Survival Rate, It refers to the probability that a patient will survive one year after receiving treatment., 1 year|Two-Years Overall Survival Rate, It refers to the probability that a patient will survive two years after receiving treatment., 2 years|AE, Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product., 1 year
Other Outcome Measures: Explore potential biomarkers in tumor tissue, ORR corresponding to PD-L1 negative expression, positive expression (TPS≥1%), low expression (\<10%), high expression (TPS\>50%), 1 year|Explore potential biomarkers in the Peripheral Blood of Cancer Patients, ORR corresponding to the absolute lymphocyte count and specific T lymphocyte count in the peripheral blood of patients, as well as the composition of oxidized lipid species., 1 year