NCT07150663招募中3 期
A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Proportion of appetite decrease assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
研究概览
简要总结
This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent (ICF).
- •Age ≥ 18 years at enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Expected survival ≥ 6 months.
- •Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
- •Planned to receive radical concurrent chemoradiotherapy.
- •Body mass index (BMI) ≤
- •At least one measurable tumor lesion according to RECIST v1.1.
排除标准
- •Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
- •Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
- •Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
- •Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (>15 mm) within one year.
- •Current radiological or clinical evidence of gastrointestinal obstruction.
研究组 & 干预措施
Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy
Experimental
干预措施: Standard Therapy (Other)
Placebo+ Standard Therapy
Placebo Comparator
干预措施: Standard Therapy (Other)
Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy
Experimental
干预措施: Nano-crystalline Megestrol Acetate Oral Suspension (Drug)
结局指标
主要结局
Proportion of appetite decrease assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
时间窗: over an 8-week period
Proportion of individuals with weight loss exceeding 5% relative to baseline
时间窗: over an 8-week period
次要结局
未报告次要终点
研究者
研究点 (1)
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