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Clinical Trials in China / NCT07396116
Starting soon Not applicable

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

NCT07396116 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Not applicable
Started
2026-02-12
Last updated
2026-02-12

Condition(s) studied

Soft Tissue Sarcoma (STS)Retroperitoneal SarcomaImmunotherapyRadiotherapy Side EffectUltra-hypofractionated Radiotherapy

Investigational drug(s) / intervention(s)

ultra-hypofractionated radiotherapy combined with immunotherapy

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07396116 on ClinicalTrials.gov ↗ ← All trials in China