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

NCT ID: NCT07253220

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-09-30

Brief Summary

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.

Conditions

Hepatitis B; Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAF Monotherapy

TAF monotherapy (TAF 25mg qd)

Group Type: OTHER

TAF monotherapy

Intervention Type: DRUG

TAF monotherapy (TAF 25 mg once daily)

ETV Combined with TAF

ETV combined with TAF (ETV 0.5 mg qd +TAF 25 mg qd）

Group Type: OTHER

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.

Intervention Type: DRUG

Combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily)

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.

Combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily)

Intervention Type: DRUG

TAF monotherapy

TAF monotherapy (TAF 25 mg once daily)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Chan Xie

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

II2025-364-02

Identifier Type: -

Identifier Source: org_study_id