To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
This is a prospective, two-cohort, multicenter clinical study. Subjects received different treatments based on their CPS scores. During induction therapy, subjects in cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score \< 10) were administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy during concurrent chemoradiotherapy. The primary endpoint was cCR rate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The study was divided into two cohorts based on CPS score, with those with CPS scores ≥10 receiving induction therapy with adebrelimab alone and those with CPS scores \<10 receiving induction therapy with adebrelimab in combination with chemotherapy. At the end of the induction period, concurrent radiotherapy treatment was administered
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGcCR
Clinical complete response rates.
Time frame: Up to 6 months.
OS
Overall survival.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 5 years.
PFS
Progression free survival.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
ORR
Objective response rate.
Time frame: Up to 6 months.
DoR
During of response.
Time frame: Up to 3 years.
DCR
Disease control rate.
Time frame: Up to 6 months.
Completion rate of concurrent radiotherapy
Calculate the percentage of patients who have completed concurrent radiochemotherapy.
Time frame: Up to 6 months.
AE
Adverse event,
Time frame: Up to 6 months.
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