NCT07691619招募中2 期
A Prospective, Single-Arm Phase II Clinical Study of Hypofractionated Adjuvant Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2026年7月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
研究概览
简要总结
This is a prospective, open-label, single-arm Phase II study designed to evaluate the safety of postoperative hypofractionated radiotherapy in patients with Stage II/III thymic epithelial tumors after complete resection. After a screening period of up to 28 days, eligible patients will receive adjuvant hypofractionated radiotherapy to a total dose of 40 Gy in 15 fractions, delivered once daily at 2.67 Gy per fraction, 5 days per week over 3 weeks. The study will primarily assess treatment-related safety and tolerability, with preliminary evaluation of efficacy, economic burden, and quality of life.
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
- •Patients who voluntarily agree to participate in this study, sign the informed consent form, demonstrate good compliance, and are willing to comply with scheduled follow-up visits.
- •Age 18-75 years, male or female.
- •Histopathologically confirmed thymoma or thymic carcinoma after R0 complete resection. Eligible disease stages according to the Masaoka-Koga staging system include Stage II-III thymic carcinoma, Stage IIA Type B3 thymoma, Stage IIB Type B2/B3 thymoma, and Stage III thymoma.
- •Eastern Cooperative Oncology Group performance status of 0-
- •Life expectancy of at least 3 months.
- •Adequate major organ function to meet the requirements of study treatment, including bone marrow, hepatic, renal, and coagulation function according to protocol-specified criteria.
- •Patients with reproductive potential must agree to use medically acceptable contraception during study treatment and for 6 months after completion of study treatment. Female patients of childbearing potential must have a negative pregnancy test before enrollment and must not be breastfeeding.
排除标准
- •Patients who do not meet the protocol-specified requirements for pathological type, disease stage, or histological subtype.
- •Patients who have not undergone surgical treatment, or who underwent R1 or R2 resection, or who have definite gross residual disease.
- •Prior thoracic radiotherapy.
- •Major surgery other than the tumor resection procedure or severe trauma within 4 weeks before the first radiotherapy treatment.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Prior or ongoing non-protocol-specified antitumor therapy, including immunotherapy, targeted therapy, radiotherapy, or other investigational treatment.
- •Active autoimmune disease or a history of severe autoimmune disease that, in the investigator's judgment, makes the patient unsuitable for radiotherapy.
- •History of immunodeficiency, including HIV positivity, history of organ transplantation, or history of allogeneic bone marrow transplantation.
- •Uncontrolled severe cardiovascular disease, such as New York Heart Association Class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or severe arrhythmia requiring clinical intervention.
- •Severe infection within 4 weeks before the first radiotherapy treatment, or active pulmonary inflammation indicated by baseline imaging.
- •History of interstitial lung disease, history of non-infectious pneumonitis, or Grade 3 or higher pulmonary dysfunction confirmed by pulmonary function testing.
- •Active pulmonary tuberculosis, active hepatitis B infection, or active hepatitis C infection.
- •Diagnosis of another malignancy before the first radiotherapy treatment, except for low-risk malignancies that have been adequately treated.
- •Any other condition that, in the investigator's judgment, may affect patient safety, compliance, or the collection of study data.
研究组 & 干预措施
RT
Experimental
干预措施: Postoperative hypo-fractionated radiotherapy (Radiation)
结局指标
主要结局
Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
时间窗: Up to 3 months
Percentage of participants who experience treatment-related Grade 2 or higher acute adverse events from the start of radiotherapy to 3 months after completion of radiotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
次要结局
- Disease-Free Survival(Up to 3 years)
- Overall Survival(Up to 3 years)
- Locoregional Recurrence Rate(Up to 3 years)
- Distant Metastasis Rate(Up to 3 years)
- All-Cause Mortality Rate(Up to 3 years)
- Incidence of Treatment-Related Late Adverse Events(From 6 months after completion of radiotherapy to 3 years)
- Total Economic Cost(Up to 3 years)
- Quality of Life Score Assessed by EORTC QLQ-C30(Up to 3 years)
- Swallowing Function Score Assessed by the Standardized Swallowing(Up to 3 years)
研究者
研究点 (1)
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