NCT07565415尚未招募2 期
A Multicenter, Randomized, Controlled Phase II Clinical Trial of Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The proportion of patients with >5% weight loss from baseline.
研究概览
简要总结
Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on quality of life, inflammatory markers, nutritional indicators, and psychological stress in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Exploratory Objective: To explore the impact of nanocrystalline megestrol acetate versus placebo on survival benefit in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology
- •No previous receipt of immunotherapy and/or targeted drug therapy
- •Child-Pugh score ≤ 7
- •At least one measurable lesion per RECIST 1.1 criteria; lesions without prior radiotherapy, cryotherapy or other local treatment
- •Single intrahepatic lesion < 10 cm, or fewer than 10 intrahepatic lesions with tumor burden < 50%
- •Meet precachexia criteria: non-volitional weight loss ≤ 5% in 6 months, plus systemic inflammation (CRP > 5 mg/L) or decreased appetite (FAACT-A/CS-12 score ≤ 37 points)
- •Meet cachexia criteria: accompanied by decreased appetite or systemic inflammation, with either non-volitional weight loss > 5% in 6 months or BMI < 18.5 kg/m² plus weight loss > 2%
- •Voluntarily participate and sign informed consent
- •Age ≥ 18 years, male or female
- •Able to swallow tablets normally
- •ECOG performance status 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate major organ function without blood products or colony-stimulating factors within 14 days
- •Hematology: ANC ≥ 1.5×10⁹/L, Hb ≥ 80 g/L, PLT ≥ 50×10⁹/L
- •Liver function: TBIL ≤ 1.5×ULN, AST/ALT ≤ 5.0×ULN, ALB ≥ 28 g/L
- •Coagulation function: INR, PT or aPTT ≤ 1.5×ULN
- •Renal function: SCr ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min
- •Urine protein ≤ 1+ or 24-hour urine protein < 1.0 g
- •Cardiac function: LVEF ≥ 50%
- •Females of childbearing potential with negative pregnancy test within 3 days before first dosing
- •Fertile male and female patients agree to effective contraception from screening to 120 days after last study drug
- •HBV/HCV infected patients receive stable antiviral therapy without drug interaction
排除标准
- •Active or untreated CNS metastases; inadequately controlled metastatic brain or leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Thromboembolic disease, ascites or lower limb edema within 6 months
- •History of other malignancies within 5 years before randomization, except curable low-risk tumors
- •Unresolved adverse toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (CTCAE v5.0), excluding alopecia
- •Pregnant, breastfeeding females or those planning pregnancy during the study
- •Any unstable medical, psychiatric or social condition that may interfere with study participation
- •Positive HIV infection
- •Major surgery within 28 days prior to randomization
- •Severe cardiovascular disease, myocardial infarction, unstable arrhythmia, angina or cerebrovascular events
- •Severe systemic infection within 4 weeks before dosing or active infection requiring systemic anti-infective treatment
- •Impaired gastrointestinal absorption, long-term tube feeding, parenteral nutrition or eating disorders
- •Concomitant use of other appetite-enhancing or weight-stimulating agents
- •Cushing's syndrome, adrenal or pituitary insufficiency, poorly controlled diabetes
- •Uncontrolled hypertension despite oral antihypertensive treatment
- •Esophagogastric varices, severe ulcers, gastrointestinal bleeding, obstruction, perforation or fistula within 6 months
- •Known hypersensitivity to any component of the investigational product
- •Any other condition considered inappropriate for enrollment by the investigator.
研究组 & 干预措施
Nanocrystalline megestrol acetate
Experimental
干预措施: Nanocrystalline megestrol acetate (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients with >5% weight loss from baseline.
时间窗: Percentage weight change at Week 12 compared to baseline
Weight is measured in kilograms (kg).
次要结局
- L3-SMI(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).)
- The incidence and severity of adverse events (AEs) assessed by CTCAE5.0(Adverse events (AEs) of each subject will be followed up for 30 days after the last dose of nanocrystalline megestrol acetate or until the initiation of new anti-tumor therapy, whichever occurs first.)
- Objective Response Rate(Baseline(day1), and after every two treatment cycles(up to 2 years).each cycle lasts 21-28 days.)
- Life quality(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).)
- Overall Survival(Baseline(day 1); prior to dosing in each systemic treatment cycle(up to 2 years,each cycle is 21-28 days), assessed up to 100 weeks.)
- Inflammatory markers(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).)
- Anxiety and depression(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days).)
- Progression-Free Survival(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle lasts 21-28 days)with a maximum follow-up of 100 weeks.)
- Appetite status assessment(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).)
- Nutritional indicators(Baseline(day1); prior to dosing in each systemic treatment cycle(each cycle is 21-28 days).)
研究者
研究点 (1)
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