NCT07396116尚未招募不适用
Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年2月12日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Peri-operative complications
研究概览
简要总结
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hypofractionated Radiotherapy Combined with Immunotherapy
Experimental
Patients receive hypofractionated radiotherapy with 43.5Gy in 15 fractions, combined with immunotherapy, followed by surgery done at 6-10 weeks post-radiotherapy (RT).
干预措施: ultra-hypofractionated radiotherapy combined with immunotherapy (Radiation)
结局指标
主要结局
Peri-operative complications
时间窗: From surgery date up to 7 days later
The proportion of patients who suffer from
次要结局
未报告次要终点
研究者
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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