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Идёт набор NCT06951503

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

Фаза III С лечением Colorectal 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: AK112, Oxaliplatin, Irinotecan, Leucovorin and 5-FU.
Кому может быть актуально
Состояния в реестре: Colorectal 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
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Официальное название

A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer

Обзор

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.

Вмешательства

  • Препарат AK112
    iv, q2w
  • Препарат Oxaliplatin
    iv, q2w
  • Препарат Irinotecan
    iv, q2w
  • Препарат Leucovorin and 5-FU
    iv, q2w
  • Препарат Bevacizumab
    iv, q2w

Первичные конечные точки

  • Progression-free survival (PFS) assessed by blinded independent central review (BICR) [Срок оценки: Up to approximately 3 years]
Вторичные конечные точки (5)
  • Overall survival (OS) [Срок оценки: Up to approximately 5 years]
  • Progression-free survival (PFS) assessed by investigator [Срок оценки: Up to approximately 3 years]
  • Objective Response Rate (ORR) [Срок оценки: Up to approximately 3 years]
  • Duration of Response (DoR) [Срок оценки: Up to approximately 3 years]
  • Disease control rate (DCR) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

  • Signed informed consent.
  • Age ≥ 18 years and ≤ 75 years.
  • ECOG status of 0 or 1.
  • Estimated survival ≥ 3 months.
  • Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
  • Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.
  • At least one measurable disease based on RECIST v1.1.
  • 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 180 days following the last dose of study treatment.

Критерии исключения

  • Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
  • Participating in other interventional study within 4 weeks prior to the first study drug administration.
  • Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
  • Current presence of uncontrolled combined disease.
  • Active clinical infections.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
  • Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
  • Current presence of significant radiographic or clinical manifestations of GI obstruction.
  • Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
  • Pregnant or lactating women.
  • Any condition considered by the investigator to be inappropriate for enrollment.
  • Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • The Sixth Hospital,Sun Yat-sen University — Guanzhou
  • Sun Yat-sen University Cancer Center — Guanzhou

Идентификаторы

NCT: NCT06951503 · AK112-312

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗