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El ensayo clínico NCT07396116 (FUSION-02) para Soft Tissue Sarcoma (STS), Sarcoma retroperitoneal, Inmunoterapia, Efecto secundario de la radioterapia, Ultra-hypofractionated Radiotherapy está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02) 28 Inmunoterapia

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07396116 (FUSION-02) es un estudio intervencionista para Soft Tissue Sarcoma (STS), Sarcoma retroperitoneal, Inmunoterapia, Efecto secundario de la radioterapia, Ultra-hypofractionated Radiotherapy. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 12 de febrero de 2026 hasta completar 28 participantes. Dirigido por Cancer Institute and Hospital, Chinese Academy of Medical Sciences, se espera que finalice el 31 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 12 de febrero de 2026.
Resumen
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma
Título oficial

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

Condiciones médicas
Soft Tissue Sarcoma (STS)Sarcoma retroperitonealInmunoterapiaEfecto secundario de la radioterapiaUltra-hypofractionated Radiotherapy
Otros ID del estudio
  • FUSION-02
  • NCC FUSION-02
Número del NCT
NCT07396116
Inicio del estudio (real)
2026-02-12
Última actualización
2026-02-12
Fecha de finalización (estimada)
2028-12-31
Inscripción (prevista)
28
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
hypofractionated radiotherapy
retroperitoneal sarcoma
soft tissue sarcoma
immunotherapy
peri-operative complications
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalHypofractionated Radiotherapy Combined with Immunotherapy
Patients receive hypofractionated radiotherapy with 43.5Gy in 15 fractions, combined with immunotherapy, followed by surgery done at 6-10 weeks post-radiotherapy (RT).
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
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Peri-operative complications
The proportion of patients who suffer from
From surgery date up to 7 days later
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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.

  • 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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences logoCancer Institute and Hospital, Chinese Academy of Medical Sciences
Parte responsable del estudio
NINGNING LU, Investigador principal, Principle Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contactos centrales del estudio
Contacto: Ning-Ning Lu, +868611804268, [email protected]
1 Centros del estudio en 1 países

Beijing Municipality

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, 100021, China
Ning-Ning Lu, Contacto, +86 01087787630, [email protected]