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Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma 第II相・フェーズ2 37 免疫療法 全生存期間

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治験番号 NCT07188103 は 食道扁平上皮癌 に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2025年7月1日 から開始しています。37 名の参加者 の募集が計画されています。この試験は Anhui Provincial Hospital によって主導され、2027年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月23日 です。
概要
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...もっと見る
公式タイトル

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

疾患名
食道扁平上皮癌
その他の研究識別子
  • 2025KY-296
NCT番号
NCT07188103
開始日
2025-07-01
最終更新日
2025-09-23
終了予定日
2027-06-30
目標参加者数
37
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集中
キーワード
Esophageal cancer
Hypofractionated Radiotherapy
Ivonescimab
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的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.
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.
主要評価項目
評価指標指標の説明時間枠
PFS
progression free survival
From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
Advese Events
Advese Events
Assessed every 8 weeks up to 36 months from the date of enrollment
副次評価項目
評価指標指標の説明時間枠
OS
overall survival
From date of enrollment until the date of death from any cause, assessed up to 36 months
ORR
Objective Response Rate
From enrollment to the time of the second radiological evaluation
DOR
Duration of Response
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
Disease Control Rate
From enrollment to the time of second radiological evaluation
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て

  • 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:

    1. Hematology:

      1. Hemoglobin (Hb) ≥ 90 g/L
      2. White blood cell (WBC) count ≥ 1.5 × 10⁹/L
      3. Platelet count ≥ 60 × 10⁹/L

    2. Serum biochemistry:

      1. Albumin ≥ 25 g/L
      2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
      3. Total bilirubin ≤ 1.5 × ULN
      4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min

    3. 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.

  • 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.
Anhui Provincial Hospital logoAnhui Provincial Hospital
試験中央連絡先
連絡先: Huiquan Liu, +86 15005518171, [email protected]
1 1カ国の場所

Anhui

Anhui Provincal Hospital, Hefei, Anhui, 230000, China
募集中