Radiation with immunotherapy before surgery for retroperitoneal sarcoma
Tests short-course radiation plus immunotherapy before surgery in adults with retroperitoneal sarcoma.
Plain-language title generated from the registry record
Registry title: Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Trial code
- NCT07396116
- Record updated
- 12 February 2026
- Original description
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcomaRead full original descriptionShow less
Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma
Inclusion: 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: 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; 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; Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable.