Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT07120750
Brief Summary:
The goal of this clinical trial is to learn if peginterferon alfa-2b can reduce the recurrence of HBV-related liver cancer in patients who have undergone radical treatment. The study will also explore the potential benefits of peginterferon alfa-2b in achieving clinical cure and its impact on reducing liver cancer recurrence.
The trial is designed as a single-center, non-randomized, open-label study. Participants will be HBV-related liver cancer patients who have received radical treatment. The study will compare two groups: one receiving nucleos(t)ide analogues (NAs) alone and the other receiving NAs combined with peginterferon alfa-2b. The main question it aims to answer is:
Can peginterferon alfa-2b lower the 3-year recurrence rate in HBV-related liver cancer patients after radical treatment?
Participants will undergo regular follow-ups, including imaging studies and blood tests, to monitor for cancer recurrence and assess the safety of the treatment.
Detailed Description:
1. Study Background The 3-year recurrence rate of HBV-related liver cancer after radical surgery is as high as 40% to 70%. This study aims to explore whether the addition of peginterferon alfa-2b (Peg-IFNα-2b) to nucleoside (acid) analogues (NAs) can reduce the risk of recurrence through immune modulation.
2. Key Mechanism Hypotheses
Peg-IFNα-2b may reduce the reactivation of micrometastases through:
* Enhancing HBV-specific T-cell responses
* Lowering serum HBsAg levels
* Inhibiting immune suppression in the tumor microenvironment
3. Detection Methods
* Imaging Monitoring: Abdominal MRI (using LI-RADS v2018 criteria) every 12 weeks ± 7 days.
* Laboratory Tests:
* HBV DNA: COBAS® TaqMan HBV Test (LLOQ = 10 IU/mL)
* Quantitative HBsAg: Architect HBsAg QT assay
* PBMC Immune Profile: Flow cytometry (proportion of CD8+/PD-1+ T cells)
* Tissue Biomarkers: Postoperative tumor tissue PD-L1 immunohistochemistry (22C3 antibody) and T-cell infiltration score.
4. Statistical Design
* Sample size: 332 cases (power 80%, α = 0.05, expected HR = 0.6)
* Primary endpoint analysis: 3-year cumulative recurrence rate (Kaplan-Meier method + Log-rank test)
* Covariate adjustment: Cox model includes age, BCLC stage, and baseline HBsAg level.
Study:
NCT07120750
Study Brief:
Protocol Section:
NCT07120750