Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Gastric/Gastroesophageal Junction Adenocarcinoma

Официальное название

A Single-arm, Phase II Clinical Study Protocol of Lparomlimab and Tuvonralimab in Combination With Regorafenib and Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Обзор

A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma

Вмешательства

• Препарат Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy
  Iparomlimab and Tuvonralimab：5mg/kg，Intravenous infusion，Q3W regorafenib：80mg，oral administration once daily from Day 1 to Day 14 chemotherapy：XELOX or SOX

Первичные конечные точки

• Objective response rate [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (5)

• Progression-free survival (PFS) [Срок оценки: Up to approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Up to approximately 2 years]
• Duration of response (DoR) [Срок оценки: Up to approximately 2 years]
• Overall survival (OS) [Срок оценки: Up to approximately 5 years]
• The incidence and severity of adverse events (AE) during the study period (Safety) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Willing to participate in this study and has signed the informed consent form.
• Age greater than 18 years, regardless of gender.
• Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
• No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.
• PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
• At least one measurable lesion according to RECIST 1.1 criteria.
• ECOG performance status 0-1.
• Life expectancy >3 months.
• Adequate organ and marrow function:

Критерии исключения

• Known HER2-positive expression (immunohistochemistry \[IHC\] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
• Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
• Known central nervous system metastases and/or carcinomatous meningitis.
• Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
• Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
• History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0.
• Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.

8\. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.

9\. Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07148427 · QL-GasC-QIBA-3007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗