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क्लिनिकल ट्रायल NCT07188103 के लिए इसोफैगल स्क्वैमस सेल कार्सिनोमा वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma चरण II 37 इम्यूनोथेरेपी कुल उत्तरजीविता

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चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07188103 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन इसोफैगल स्क्वैमस सेल कार्सिनोमा से जुड़ा हुआ है और यह एक चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 1 जुलाई 2025 को हुई थी, और इसमें कुल 37 प्रतिभागियों के नामांकन की योजना है। Anhui Provincial Hospital इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 जून 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 23 सितंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
इसोफैगल स्क्वैमस सेल कार्सिनोमा
अन्य अध्ययन आईडी
  • 2025KY-296
NCT नंबर
NCT07188103
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-07-01
अंतिम अद्यतन प्रकाशित
2025-09-23
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-06-30
नामांकन (अनुमानित)
37
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
स्थिति
भर्ती जारी
प्रमुख शब्द
Esophageal cancer
Hypofractionated Radiotherapy
Ivonescimab
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकIvonescimab+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.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी

  • 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
अध्ययन केंद्रीय संपर्क
संपर्क: Huiquan Liu, +86 15005518171, [email protected]
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Anhui

Anhui Provincal Hospital, Hefei, Anhui, 230000, China
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