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Набор скоро начнётся NCT07396116

Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)

Без фазы С лечением Soft Tissue Sarcoma (STS) Retroperitoneal Sarcoma Immunotherapy Radiotherapy Side Effect

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: ultra-hypofractionated radiotherapy combined with immunotherapy.
Кому может быть актуально
Состояния в реестре: Soft Tissue Sarcoma (STS), Retroperitoneal Sarcoma, Immunotherapy, Radiotherapy Side Effect. 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

Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)

Обзор

To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma

Вмешательства

  • Лучевая терапия ultra-hypofractionated radiotherapy combined with immunotherapy
    ultra-hypo-fractionated radiotherapy with 43.5Gy in 15 fractions combined with immunotherapy, followed by surgery done at 6 to 10 weeks post-RT

Первичные конечные точки

  • Peri-operative complications [Срок оценки: From surgery date up to 7 days later]

Критерии участия

Критерии включения

  • Diagnosis \& Indication: Primary or recurrent abdominopelvic soft tissue sarcoma. Patients are deemed to have a high probability of R1/R2 resection with upfront surgery and are confirmed to require radiotherapy following Multidisciplinary Team (MDT) discussion.
  • Target Volume: In cases of multifocal disease, all lesions must be safely encompassable within a single radiotherapy target volume.
  • Age: Age ≥ 18 years.
  • Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0-2; American Society of Anesthesiologists (ASA) score ≤ 2; patients must be expected to tolerate surgery and radiotherapy.
  • Pathology: Histologically confirmed soft tissue sarcoma.
  • Measurability: Presence of evaluable lesions.
  • Life Expectancy: Life expectancy > 5 years.
  • Hematological \& Hepatic Function: Adequate organ function
  • Renal Function: Adequate renal function defined as Glomerular Filtration Rate (GFR) ≥ 50 ml/min (calculated by Cockcroft-Gault formula), and split renal function imaging confirms function in the contralateral kidney.
  • Contraception: Female patients of childbearing potential, or male patients with female partners of childbearing potential, must agree to use effective contraception during the entire treatment period and for 6 months after the last dose.
  • Consent: Signed informed consent form.
  • Follow-up: Capable of complying with follow-up requirements.

Критерии исключения

  • Significant Comorbidities: Patients with the following concurrent conditions: active hemorrhage, ulceration, intestinal perforation, intestinal obstruction, uncontrolled hypertension, cardiac insufficiency (NYHA Class III-IV), severe hepatic or renal dysfunction (Grade 4), mesenteric ischemia, or severe inflammatory bowel disease (IBD).
  • Excluded Histologies: Other pathological types, including Gastrointestinal Stromal Tumor (GIST), sarcomatoid carcinoma, sarcomas primarily treated with chemotherapy (e.g., rhabdomyosarcoma and PNET), desmoid fibromatosis, and benign tumors.
  • Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable.
  • Prior Radiotherapy: History of prior radiotherapy to the same anatomical region.
  • Distant Metastasis: Presence of distant metastasis (M1) confirmed by comprehensive imaging/examination within 4 weeks prior to enrollment.
  • Contraindications to Surgery/Protocol: Presence of other severe medical comorbidities that contraindicate surgery or preclude participation in the study.
  • Planned Neoadjuvant Chemotherapy: Patients scheduled to receive (concurrent) neoadjuvant chemotherapy.
  • Recent Systemic Therapy: Receipt of chemotherapy or other systemic treatments within 4 weeks prior to enrollment.

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
  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07396116 · NCC FUSION-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗