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Идёт набор NCT06404528

Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours

Без фазы С лечением Solid Tumors, Adult

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: Blood glucose stress combined with low-dose chemotherapy.
Кому может быть актуально
Состояния в реестре: Solid Tumors, Adult. 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 Clinical Study on the Efficacy and Mechanism of Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours

Обзор

By controlling the patient's blood sugar, small doses of chemotherapy are used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, and produce very strong anticancer effects without the cytotoxic effects of chemotherapy.

Вмешательства

  • Другое Blood glucose stress combined with low-dose chemotherapy
    By controlling the patient's blood sugar, low-dose chemotherapy is used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, produce very strong anticancer effects, and have no cytotoxic reactions to chemotherapy.

Первичные конечные точки

  • Relief degree of tumors [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (2)
  • Progress free survival（PFS） [Срок оценки: 3 years, year 3]
  • Overall survival（OS） [Срок оценки: 5 years, year 5]

Критерии участия

Критерии включения

  • Male or female aged 18-75 years;
  • ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
  • Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
  • ECOG score of 0-2, lifespan > 12 weeks;
  • Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
  • Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up

Критерии исключения

  • The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
  • White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
  • Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
  • HIV, HBV and HCV positive;
  • Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
  • Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
  • Patients are on anticoagulation or have severe coagulopathy (APTT>70);
  • Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
  • Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
  • Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
  • Subjects in other conditions that are considered unsuitable for this study by the investigator.-

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

Китай · 1 центр
  • Wuxi People's Hospital — Wuxi

Идентификаторы

NCT: NCT06404528 · KY23149

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗