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Идёт набор NCT06613269

68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.

Фаза II С лечением Clear Cell Renal Cell Carcinoma

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: 68Ga-NY104 PET/CT, 18F-FDG PET/CT, Radiation Therapy, Systemic therapy.
Кому может быть актуально
Состояния в реестре: Clear Cell Renal Cell Carcinoma. 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
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Официальное название

Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.

Обзор

Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.

Вмешательства

  • Препарат 68Ga-NY104 PET/CT
    68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist. The scan begins 1 hour after intravenous injection of 68Ga-NY104.
  • Препарат 18F-FDG PET/CT
    18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.
  • Лучевая терапия Radiation Therapy
    Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.
  • Препарат Systemic therapy
    Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.

Первичные конечные точки

  • Progression free survival 2, PFS2 [Срок оценки: the time from the start of RT to 4 years after treatment]
Вторичные конечные точки (10)
  • Lesion uptake on 68Ga-NY104 PET/CT [Срок оценки: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT]
  • Lesion uptake on 18F-FDG PET/CT [Срок оценки: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT]
  • Number of positive lesions detected on 68Ga-NY104 PET/CT [Срок оценки: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT]
  • Number of positive lesions detected on 18F-FDG PET/CT [Срок оценки: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT]
  • Number of lesions detected combining all available imaging modalities [Срок оценки: From the start of any imaging modality to 1 week after completion of all imaging modalities]
  • Objective response rate [Срок оценки: the time from the start of RT to 4 years after treatment]
  • Progression free survival 1, PFS1 [Срок оценки: the time from the start of RT to 4 years after treatment]
  • Disease control rate [Срок оценки: the time from the start of RT to 4 years after treatment]
  • Overall survival [Срок оценки: the time from the start of RT to 4 years after treatment]
  • Adverse event [Срок оценки: the time from the start of RT to 4 years after treatment]

Критерии участия

Критерии включения

  • Age ≥ 18 years old
  • Histologically or cytologically confirmed clear cell renal cell carcinoma
  • Eligible for radiation therapy: no more than 10 lesions in total
  • Expected survival: over 3 months
  • ECOG: 0 or 1
  • Sufficient organ function
  • Written informed consent

Критерии исключения

  • Brain metastasis/carcinomatous meningitis
  • Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer.
  • Pregnant or breastfeeding.
  • Active infection.

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
  • Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06613269 · 2024-413-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗