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Идёт набор NCT06953999

A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer

Фаза III С лечением Pancreatic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

Обзор

This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.

Вмешательства

  • Препарат Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
  • Препарат Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
  • Препарат Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
    Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Первичные конечные точки

  • Overall response (OS) [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (8)
  • Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
  • Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
  • Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
  • Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
  • Time to response (TTR) assessed by the investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
  • Adverse Events (AEs) [Срок оценки: Up to approximately 2 years]
  • Cmax and Cmin [Срок оценки: Up to approximately 2 years]
  • Anti-drug antibodies (ADA) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • Voluntarily sign a written informed consent form.
  • Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of ≥ 3 months.
  • Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
  • No prior systemic anti-cancer treatment for metastatic PDAC.
  • At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Adequate organ function.

Критерии исключения

  • Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
  • Presence of active central nerve system (CNS) metastases.
  • Known germline BRCA1/2 or PALB2 mutations.
  • Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
  • History of other malignancies within the past 5 years.
  • History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
  • Previous anti-angiogenic therapy and immunotherapy.
  • Active autoimmune disease requiring systemic treatment within the past 2 years.
  • Pregnant or breastfeeding women.
  • Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • Harbin Medical University Cancer Hospital — Харбин
  • Fudan University Shanghai Cancer Center — Шанхай
  • Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT06953999 · AK112-310

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗