Actively Recruiting
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Led by Anhui Provincial Hospital · Updated on 2025-09-23
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed esophageal squamous cell carcinoma aged 18 to 80 years
- Unresectable locally advanced, recurrent after surgery, or metastatic ESCC progressed on or intolerant to first-line systemic therapy
- Disease progression during or within 6 months after definitive concurrent chemoradiotherapy counts as first-line failure
- At least one measurable lesion according to RECIST 1.1 criteria
- Adequate blood counts: Hemoglobin ≥ 90 g/L, White blood cells ≥ 1.5 × 10⁹/L, Platelets ≥ 60 × 10⁹/L
- Adequate liver and kidney function: Albumin ≥ 25 g/L, ALT and AST ≤ 2.5 × upper limit of normal, Total bilirubin ≤ 1.5 × upper limit of normal, Serum creatinine ≤ 1.5 × upper limit or creatinine clearance ≥ 60 mL/min
- Left ventricular ejection fraction ≥ 50%
- ECOG performance status 0 to 2
- Expected survival of at least 3 months
- Voluntary informed consent and willingness to comply with study procedures and follow-up
You will not qualify if you...
- Severe organ dysfunction, uncontrolled acute infection, or major comorbidities
- Vertebral metastases with spinal cord compression symptoms
- Presence of esophagotracheal or esophagomediastinal fistulas
- Uncontrolled pleural, pericardial, or pelvic effusions needing repeated drainage
- Esophageal lesions invading heart or great vessels with risk of life-threatening bleeding
- Esophageal lesions invading trachea or bronchi with risk of esophagotracheal fistula
- Unsuitable for short-course hypofractionated radiotherapy as assessed by physician
- Pregnant or lactating women
- Mental disorders or history of psychotropic drug abuse unable to quit
- Participation in other drug trials within past 4 weeks
- Refusal by patient or family to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincal Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
H
Huiquan Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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