Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study
Sponsor: Anhui Provincial Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
PFS
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
Time frame: Assessed every 8 weeks up to 36 months from the date of enrollment
Secondary Endpoints
OS
ORR
DOR
Eligibility Criteria
Inclusion Criteria: * a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years; * b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure; * c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station; * d. Adequate major organ function, defined as: 1. Hematology: 1. Hemoglobin (Hb) ≥ 90 g/L 2. White blood cell (WBC) count ≥ 1.5 × 10⁹/L 3. Platelet count ≥ 60 × 10⁹/L 2. Serum biochemistry: 1. Albumin ≥ 25 g/L 2. Alanine aminotransferase (ALT) and aspartate aminotransferase …
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