Status:
RECRUITING
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- Hematology:
- Hemoglobin (Hb) ≥ 90 g/L
- White blood cell (WBC) count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 60 × 10⁹/L
- Serum biochemistry:
- Albumin ≥ 25 g/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
- Echocardiography:
- Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
- e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;
- f. Expected survival ≥ 3 months;
- g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.
Exclusion
- a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
- b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
- c. Patients with esophagotracheal or esophagomediastinal fistulas;
- d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
- e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
- f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;
- g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;
- h. Pregnant or lactating women;
- i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;
- j. Patients who have participated in other drug clinical trials within the past 4 weeks;
- k. Patients or their families who refuse to participate in the study.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT07188103
Start Date
July 1 2025
End Date
June 30 2027
Last Update
September 23 2025
Active Locations (1)
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1
Anhui Provincal Hospital
Hefei, Anhui, China, 230000