A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Официальное название

A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy

Обзор

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.

Подробное описание

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.

Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.

Вмешательства

• Препарат HS-20093 for Injection
  The patient will receive treatment with HS-20093.
• Препарат Irinotecan; Paclitaxel; Docetaxel
  The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Approximately 4 years after the first patient with first dose]

Вторичные конечные точки (6)

• Progression-free survival (PFS) assessed by investigator [Срок оценки: Approximately 3 years after the first patient with first dose]
• Objective response rate (ORR) [Срок оценки: Approximately 2 years after the first patient with first dose]
• Disease control rate (DCR) [Срок оценки: Approximately 2 years after the first patient with first dose]
• Duration of response (DoR) [Срок оценки: Approximately 3 years after the first patient with first dose]
• Incidence and severity of AEs [Срок оценки: From the first dose until 90 days after the last dose]
• Incidence and severity of SAEs [Срок оценки: From the first dose until 90 days after the last dose]

Критерии участия

Критерии включения

• Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
• Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
• Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
• Presence of at least one target lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
• Minimum life expectancy >12 weeks.
• Adequate organ function.
• Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
• Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

Критерии исключения

• 1\. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:

• Prior or current treatment targeting B7-H3;
• Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.

5\. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.

9\. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.

10\. Known to have allergic reactions or contraindications to the investigational medicinal product.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07621601 · HS-20093-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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