OncoMatch/Clinical Trials/NCT07188103
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Is NCT07188103 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ivonescimab+Radiotherapy for esophageal squamous cell carcinoma.
Treatment: Ivonescimab+Radiotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line
progressed on or is intolerant to first-line systemic therapy
Cannot have received: other drug clinical trials
Patients who have participated in other drug clinical trials within the past 4 weeks
Lab requirements
Blood counts
Hemoglobin (Hb) ≥ 90 g/L; White blood cell (WBC) count ≥ 1.5 × 10⁹/L; Platelet count ≥ 60 × 10⁹/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
Liver function
ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN; Albumin ≥ 25 g/L
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
Adequate major organ function, defined as: Hematology: Hemoglobin (Hb) ≥ 90 g/L; WBC ≥ 1.5 × 10⁹/L; Platelet ≥ 60 × 10⁹/L. Serum biochemistry: Albumin ≥ 25 g/L; ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 60 mL/min. Echocardiography: LVEF ≥ 50% (lower limit of normal)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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