Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 3:17 AM
Study NCT ID:
NCT07120750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis
Sponsor:
Shenzhen Third People's Hospital
Organization:
Study Overview
Official Title:
The Impact of Different Antiviral Strategies on Tumor Prognosis in Patients With HBV-related Liver Cancer After Radical Treatment: A Prospective, Open-label, Non-randomized Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRTRAS 001
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: