Prospective, Randomized, Controlled Clinical Study Comparing TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- 24-month overall survival (OS) after initiation of systemic therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced HBV-related hepatocellular carcinoma.
研究概览
简要总结
Study Objective: To compare the efficacy and prognosis of systemic cancer therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced hepatitis-B-related hepatocellular carcinoma (HBV-HCC).
Study Design: Prospective, interventional cohort study. Participants: Patients with histologically or radiologically confirmed unresectable, advanced HBV-HCC who are scheduled to receive immune-based systemic therapy at The Third Affiliated Hospital of Sun Yat-sen University. Detailed inclusion/exclusion criteria are provided below.
Intervention: Enrolled participants will be assigned to receive either TAF monotherapy or ETV combined with TAF for HBV suppression.
Primary Outcome: Overall survival (OS) at 24 months after initiation of systemic therapy, compared between the two HBV-treatment strategies.
Secondary Outcomes: Decline in HBV DNA and HBsAg levels at 1, 3, 12 and 24 months.
Sample Size: 120 HCC patients (60 per arm). Statistical Analysis: All analyses will be performed with SPSS. Continuous variables will be tested for normality (Shapiro-Wilk). Normally distributed data are presented as mean ± SD; non-normally distributed data as median (IQR). Twenty-four-month OS will be estimated by Kaplan-Meier curves and compared with a Cox proportional-hazards model adjusted for age, BCLC stage, AFP level, and ICI regimen. PFS will be compared using the log-rank test; ORR and HBV DNA undetectable rate will be compared with χ² tests. Inverse-probability-of-treatment weighting (IPTW) will address selection bias, and multiple imputation will handle missing data.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, positive HBsAg for ≥ 6 months, and HBV DNA ≥ 2,000 IU/mL within 2 weeks before enrollment;
- •Histologically or clinically confirmed unresectable or metastatic hepatocellular carcinoma, Child-Pugh class A or B, ECOG performance status 0-1, and scheduled to receive systemic immunotherapy in the Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University;
- •At least one measurable lesion that has either not undergone local therapy or has progressed after local therapy, as defined by modified RECIST (mRECIST); ④ Estimated life expectancy ≥ 12 weeks; ⑤ Signed informed consent form for study participation
排除标准
- •Co-infection with HCV or HIV; ② History of organ transplantation; ③ Presence of cardiac or renal insufficiency, or active autoimmune disease that constitutes a contraindication to immunotherapy.
研究组 & 干预措施
TAF Monotherapy
TAF monotherapy (TAF 25mg qd)
干预措施: TAF monotherapy (Drug)
ETV Combined with TAF
ETV combined with TAF (ETV 0.5 mg qd +TAF 25 mg qd）
干预措施: The arm will receive combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily); after HBV DNA becomes undetectable, the combination group will switch to TAF monotherapy. (Drug)
结局指标
主要结局
24-month overall survival (OS) after initiation of systemic therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced HBV-related hepatocellular carcinoma.
时间窗: 24 months
24-month overall survival (OS)
次要结局
未报告次要终点
研究者
Chan Xie
Ph.D
Sun Yat-sen University