TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT07253220
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    Combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily)
  • TAF monotherapy — DRUG
    TAF monotherapy (TAF 25 mg once daily)

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: TAF Monotherapy
    TAF monotherapy (TAF 25mg qd)
  • Other: ETV Combined with TAF
    ETV combined with TAF (ETV 0.5 mg qd +TAF 25 mg qd）

Primary Outcome Measure

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. [ Time Frame: 24 months ]

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