NCT05167994招募中2 期
Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Major wound complications
研究概览
简要总结
To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
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
- •Age older than 18-yo
- •Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
- •Histology reviewed by reference pathologist
- •Lesion can be assessed
- •Can tolerate radiotherapy and Anlotinib
- •Agree contraception.
- •Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
排除标准
- •No gross tumor post-resection in other center.
- •Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
- •Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
- •Benign histology
- •Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
- •STS can be cured by extensive operation alone.
- •Previous irradiation to the same area
- •Radiological evidence of distant metastases
- •Other contraindications, can't tolerate operation or other treatment needed in this study.
- •Neoadjuvant chemotherapy given or planned.
结局指标
主要结局
Major wound complications
时间窗: 4-months post-surgery
次要结局
- Pathological remission rate(2 weeks after operation)
- Acute and late toxicities(acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months)
- Extremity function(pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up)
- Overall Survival(2-year)
- Local control(2-year)
- Quality of Life(pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up)
研究者
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (2)
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