NCT06500234招募中3 期
Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
详细描述
Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer, malnutrition Age >18 years Performance status ECOG of 0 or
- •Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.
- •For all oral medications patients must be able to comfortably swallow capsules;
排除标准
- •Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.
- •Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.
研究组 & 干预措施
megestrol acetate-olanzapine
Experimental
Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday
干预措施: Megestrol Acetate and olanzapine (Drug)
control
Placebo Comparator
Starch powder 50 mg, oral, everyday,
干预措施: Starch powder 50 mg (Drug)
结局指标
主要结局
ORR
时间窗: 12 months
overall response rate
次要结局
- PFS(12 months)
研究者
研究点 (1)
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