In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.
Anhui Provincal Hospital
Hefei, Anhui, China
RECRUITINGPFS
progression free survival
Time frame: From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
Advese Events
Advese Events
Time frame: Assessed every 8 weeks up to 36 months from the date of enrollment
OS
overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 36 months
ORR
Objective Response Rate
Time frame: From enrollment to the time of the second radiological evaluation
DOR
Duration of Response
Time frame: the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.
DCR
Disease Control Rate
Time frame: From enrollment to the time of second radiological evaluation
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