Идёт набор NCT06341335
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
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: cadonilimab, pulocimab, paclitaxel, placebo.
- Кому может быть актуально
- Состояния в реестре: Gastric and Gastroesophageal Junction Adenocarcinoma. 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, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy
Обзор
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
Вмешательства
- Препарат cadonilimab
iv, q3w - Препарат pulocimab
iv, q3w - Препарат paclitaxel
iv, q3w - Препарат placebo
iv, q3w
Первичные конечные точки
- Progression-free survival (PFS) assessed by blinded independent central review (BICR) [Срок оценки: Up to 2 years]
- Overall survival (OS) [Срок оценки: Up to 2 years]
Вторичные конечные точки (4)
- Progression-free survival (PFS) assessed by investigator [Срок оценки: Up to 2 years]
- Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
- Duration of Response (DoR) [Срок оценки: Up to 2 years]
- Disease control rate (DCR) [Срок оценки: Up to 2 years]
Критерии участия
Критерии включения
- Signed informed consent
- Age ≥ 18 years and ≤ 75 years
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
- At least one measurable disease based on RECIST v1.1
- ECOG status of 0 or 1
- Estimated survival ≥ 3 months
- Adequate organ function per protocol-defined criteria
- Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
Критерии исключения
- Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
- HER2-positive
- Known other invasive malignancies within 3 years
- Subjects who are currently participating in other interventional study
- Received prior systemic anti-tumour therapy within 4 weeks before randomization
- Previous systemic treatment with taxane within 6 months before randomization
- Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
- In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
- History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
- History of severe infection within 4 weeks prior to randomization
- Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
- Major surgical procedure or serious trauma within 28 days prior to randomization
- History of interstitial lung disease or noninfectious pneumonitis
- Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
- Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
- History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
- Use of live vaccines within 30 days prior to randomization
- Pregnant or lactating women.
- Any condition considered by the investigator to be inappropriate for enrollment
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 · 1 центр
- Peking University Cancer Hospital & Institute — Пекин
Идентификаторы
NCT: NCT06341335 · AK109-301