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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 (Jun 2026). This Phase 2 trial studies Ivonescimab+Radiotherapy for esophageal squamous cell carcinoma.

Phase 2RecruitingAnhui Provincial HospitalNCT07188103Data as of Jun 2026Location: China

Treatment: Ivonescimab+RadiotherapyIn 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.

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Extracted eligibility criteria

Treatments studied

Other

Ivonescimab+Radiotherapy

Cancer type

Esophageal Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 80

Prior therapy

Min 1 prior line

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.

Frequently asked questions

Is NCT07188103 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior other drug clinical trials disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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