NCT06749678尚未招募不适用
Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Patients With Unresectable Hepatocellular Carcinoma: a Prospective, Open, Randomized Controlled Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Complication Composite Index (CCI) at 30 days postoperatively
研究概览
简要总结
This is a prospective, randomised controlled clinical trial to study the impact of prehabilitation on postoperative complications, physical function, quality of life, and short-term survival outcomes in patients with unresectable liver cancer undergoing conversion therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.
- •Patients must have an initial diagnosis of unresectable hepatocellular carcinoma (HCC) confirmed by EASL/AASLD diagnostic criteria, pathological histology, or cytology, and must be planned for conversion therapy.
- •Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.
- •Patients must be physically capable of participating in exercise training, defined as the ability to walk continuously on flat ground for more than 200 meters without rest and to climb two flights of stairs consecutively without requiring a break.
- •Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.
- •Patients must voluntarily enroll in the study, be able to provide written informed consent, and be capable of understanding and adhering to the trial protocol and follow-up procedures.
排除标准
- •A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
- •Presence of extrahepatic metastases or concurrent other malignant tumors.
- •Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
- •Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
- •Pregnant or breastfeeding women.
- •Individuals with severe and irreversible cardiac, pulmonary, or renal organic diseases, or severe anemia, which would make them unsuitable for preoperative rehabilitation programs. -
结局指标
主要结局
Complication Composite Index (CCI) at 30 days postoperatively
时间窗: 30 days after surgery
Surgical patients were scored based on the severity and number of complications that occurred within 30 days after surgery.
次要结局
- 30-Day Postoperative Mortality Rate(30 days after surgery)
- Six-Minute Walk Distance (6MWD)(Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively.)
- The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score(Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively)
- The Generalized Anxiety Disorder 7-item scale (GAD-7) Score(Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively)
- The Patient Health Questionnaire-9 (PHQ-9) Depression Scale Score(Baseline, each cycle of therapy, the time of surgery, and at 2、6 weeks and 6 months postoperatively)
- The incidence and severity of postoperative complications.(30 days after surgery)
- Adverse Events Related to Conversion Therapy(Up to approximately 2 years)
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
研究者
研究点 (1)
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