NCT07342322尚未招募2 期
A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma
First Affiliated Hospital of Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The primary objective of this clinical trial is to evaluate the efficacy and safety of spatially fractionated radiotherapy combined with the PraG strategy in the treatment of soft tissue sarcoma (STS). The main questions it aims to answer are:
- Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients?
- What medical adverse events and clinical problems will participants encounter during the treatment with spatially fractionated radiotherapy combined with the PraG strategy? Researchers will administer a combined therapeutic regimen consisting of spatially fractionated radiotherapy, Toripalimab, recombinant human granulocyte-macrophage colony-stimulating factor injection, and Thymalfasin injection to enrolled patients, so as to observe the efficacy and safety of this therapeutic strategy for soft tissue sarcoma.
Participants will:
- The treatment will be divided into two major phases: the radiotherapy phase and the immunotherapy phase, with concomitant immunomodulatory supportive therapy administered throughout the entire treatment course.
- The total duration of treatment will last for 1 year starting from the first dose of medication, with regular clinical evaluations conducted according to the individual disease characteristics of each patient.
- Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months.
- Routine follow-up examinations will be performed at an interval of 8/12 weeks.
- Clinical symptoms, imaging indicators, biochemical parameters and survival status of all participants will be systematically recorded and documented throughout the study period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old, both genders are eligible.
- •Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:
- •Undifferentiated pleomorphic sarcoma
- •Liposarcoma
- •Leiomyosarcoma
- •Synovial sarcoma
- •Fibrosarcoma
- •Other high-grade soft tissue sarcomas
- •Disease Stage:
- •Locally advanced, unresectable soft tissue sarcoma, or
- •Recurrent or metastatic soft tissue sarcoma
- •Prior Therapy:
- •Prior surgery, radiotherapy, or chemotherapy is allowed.
- •At least 4 weeks since the last anti-tumor treatment.
- •Prior treatment-related toxicities have resolved to ≤Grade 1 (except alopecia).
- •Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.
- •Performance Status: ECOG performance status score of 0-
- •Life Expectancy: ≥3 months.
- •Organ Function:
- •Hematology: Hemoglobin ≥50 g/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥60×10⁹/L
- •Liver Function: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastasis)
- •Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min
- •Cardiac Function: Left ventricular ejection fraction ≥40%
- •Informed Consent: The patient or their legal representative has signed the informed consent form.
排除标准
- •Special Types of Sarcoma:
- •Gastrointestinal Stromal Tumor (GIST)
- •Osteosarcoma
- •Ewing's Sarcoma
- •Prior Treatment History:
- •Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose
- •Major surgery within 4 weeks
- •Concurrent Diseases:
- •Active autoimmune diseases
- •Diseases requiring systemic immunosuppressive therapy
- •Severe cardiovascular diseases (myocardial infarction, unstable angina, heart failure, etc.)
- •Severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, etc.)
- •Active infections requiring systemic anti-infective therapy
- •Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.
- •Pregnancy and Lactation: Women who are pregnant or breastfeeding.
- •Allergy History: Known allergies to the drugs or their components involved in the study.
研究组 & 干预措施
SFRT + PraG
Experimental
干预措施: Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: week 4
次要结局
- Disease Control Rate(week 4)
研究者
研究点 (1)
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