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Набор скоро начнётся NCT07166263

Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer

Ранняя фаза I С лечением Gastric Cancer (GC) Colorectal 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: NK510, NK510.
Кому может быть актуально
Состояния в реестре: Gastric Cancer (GC), Colorectal Cancer. Базовые параметры: от 18 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

Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer

Обзор

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.

Вмешательства

  • Препарат NK510
    NK510 will be administered through intravenous infusion, once a week for a total of six times.
  • Препарат NK510
    NK510 will be administered through intraperitoneal perfusion on D1, D4, and D7 of the first week for a total of 3 times, with each 3-week cycle constituting a total of 2 cycles.

Первичные конечные точки

  • Dose-Limiting Toxicity [Срок оценки: 6 weeks]
  • Overall response rate (ORR) [Срок оценки: 6 weeks]
  • Puncture-free survival (PuFS) [Срок оценки: 6 weeks]
Вторичные конечные точки (1)
  • Progression-free survival (PFS) [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Aged ≥ 18 years, regardless of gender.
  • Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.
  • Progressive disease or recurrence after receiving ≥ 2 lines of treatment.
  • Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:
  • Drained ascites ≥ 500ml, or B-ultrasound/CT in the supine position shows ascites depth ≥ 3cm.
  • Peritoneal metastasis confirmed by any of the following criteria:

i. Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry.

  • At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
  • ECOG performance status of 0-2.
  • Expected survival period ≥ 3 months.
  • Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study.

Критерии исключения

  • Pregnant or lactating women.
  • Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis with obvious symptoms.
  • A history of other malignant tumors within the past 3 years.
  • Subjects with active, known or suspected autoimmune diseases \[excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers\].
  • Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
  • A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.; QTc interval > 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before enrollment; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) < 50%; clinically uncontrolled hypertension.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University — Нанкин

Идентификаторы

NCT: NCT07166263 · NK510-13

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗