Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Ivonescimab+Radiotherapy
  Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.

Первичные конечные точки

• PFS [Срок оценки: From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months]
• Advese Events [Срок оценки: Assessed every 8 weeks up to 36 months from the date of enrollment]

Вторичные конечные точки (4)

• OS [Срок оценки: From date of enrollment until the date of death from any cause, assessed up to 36 months]
• ORR [Срок оценки: From enrollment to the time of the second radiological evaluation]
• DOR [Срок оценки: the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.]
• DCR [Срок оценки: From enrollment to the time of second radiological evaluation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Provincal Hospital — Хэфэй

Идентификаторы

NCT: NCT07188103 · 2025KY-296

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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