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| Name | Class |
|---|---|
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Ningbo Mingzhou Hospital (Affiliated to Zhejiang University) | UNKNOWN |
| Shulan (Hangzhou) Hospital | OTHER |
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The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:
Researchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2b combined with NAs | Experimental | Patients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF/TAF/TMF) |
|
| NAs alone | Active Comparator | Patients receive first-line nucleos(t)ide analogues (TDF/TAF/TMF) alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b | Drug | Peginterferon alfa-2b injection administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg) | Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA). Unit: IU/mL | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Proportion of patients with HBsAg loss | Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) determined by CMIA. Unit: % of patients | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Proportion of patients with HBsAg seroconversion | Proportion of patients with HBsAg loss (HBsAg < 0.05 IU/mL) and anti-HBs seropositivity (anti-HBs ≥ 10 mIU/mL) determined by CMIA. Unit: % of patients | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) | Serum HBV DNA viral load quantified by a TaqMan-based real-time quantitative polymerase chain reaction (qPCR) assay. Unit: IU/mL | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Concentration of Hepatitis B e Antigen (HBeAg) |
| Measure | Description | Time Frame |
|---|---|---|
| The Levels of Thyroid Stimulating Hormone (TSH) | TSH measured by chemiluminescent immunoassay (CLIA). Unit: mIU/L | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Free Triiodothyronine (FT3) | FT3 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyun Fu | Contact | +86 13777966906 | nbfly2009@126.com | |
| Mengyuan Hu | Contact | +86 17858767819 | hmy_helen@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shulan (Hangzhou) Hospital | Hangzhou | Zhejiang | 310022 | China |
IPD sharing is not planned for this investigator-initiated study. Data will be used only for the primary study analysis and reporting.
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| TDF | Drug | Tenofovir disoproxil fumarate |
|
| TAF | Drug | Tenofovir alafenamide |
|
| TMF | Drug | Tenofovir amibufenamide |
|
Serum HBeAg concentration assessed by CMIA. Unit: S/CO |
| Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Composition and diversity of intestinal microbiota | Intestinal microbiota analyzed by 16S rRNA gene high-throughput sequencing. Unit: Relative abundance (%) and alpha diversity index | Baseline, Week 24, Week 48 |
| Recurrence-Free Survival (RFS) | Time to first hepatocellular carcinoma (HCC) recurrence or death from any cause, which is confirmed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). Unit: Months | Years 1, 2, 3, 5 |
| Overall survival (OS) | Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months | Years 1, 2, 3, 5 |
| Concentration of Interleukin-2 (IL-2) | Serum levels of IL-2 will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Concentration of Interleukin-4 (IL-4) | Serum levels of IL-4 will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Concentration of Interleukin-6 (IL-6) | Serum levels of IL-6 will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Concentration of Interleukin-10 (IL-10) | Serum levels of IL-10 will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Concentration of Tumor Necrosis Factor-α (TNF-α) | Serum levels of TNF-α will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Concentration of Interferon-γ (IFN-γ) | Serum levels of IFN-γ will be measured using cytometric bead array (CBA). Unit: pg/mL | Baseline, Week 24, Week 48 |
| Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Free Thyroxine (FT4) | FT4 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Thyroglobulin Antibody (TgAb) | TgAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Thyroid Peroxidase Antibody (TPOAb) | TPOAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL | Baseline, Weeks 12, 24, 36, 48 |
| Concentration of Alpha-fetoprotein (AFP) | AFP measured by CLIA. Unit: ng/mL | Baseline, Weeks 12, 24, 36, 48, 96, 144, 192 |
| Serum levels of Protein induced by vitamin K absence-II (PIVKA-II) | PIVKA-II measured by chemiluminescence immunoassay (CLIA). Unit: mAU/mL | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Red Blood Cell count (RBC) | RBC measured by automated hematology analyzer. Unit: ×10¹²/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of White Blood Cell (WBC) | WBC measured by automated hematology analyzer. Unit: ×10⁹/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Platelet (PLT) | PLT measured by automated hematology analyzer. Unit: ×10⁹/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Absolute Neutrophil Count (ANC) | ANC measured by automated hematology analyzer. Unit: ×10⁹/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Absolute Lymphocyte Count (ALC) | ALC measured by automated hematology analyzer. Unit: ×10⁹/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Absolute Monocyte Count (AMC) | AMC measured by automated hematology analyzer. Unit: ×10⁹/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Hemoglobin (Hb) | Hb measured by automated hematology analyzer. Unit: g/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Alanine Aminotransferase (ALT) | ALT measured by automated biochemical analyzer. Unit: IU/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Aspartate Aminotransferase (AST) | AST measured by automated biochemical analyzer. Unit: IU/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Alkaline Phosphatase (ALP) | ALP measured by automated biochemical analyzer. Unit: IU/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Gamma-Glutamyl Transferase (GGT) | GGT measured by automated biochemical analyzer. Unit: IU/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Total Bilirubin (TBil) | TBil measured by automated biochemical analyzer. Unit: μmol/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Direct Bilirubin (DBil) | DBil measured by automated biochemical analyzer. Unit: μmol/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Indirect Bilirubin (IBil) | IBil measured by automated biochemical analyzer. Unit: μmol/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Alpha-L-Fucosidase (AFU) | AFU measured by automated biochemical analyzer. Unit: U/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Albumin (ALB) | ALB measured by automated biochemical analyzer. Unit: g/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Levels of Estimated Glomerular Filtration Rate (eGFR) | eGFR measured by automated biochemical analyzer. Unit: ml/min | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| Serum Levels of Creatinine (Cr) | Cr measured by automated biochemical analyzer. Unit: μmol/L | Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240 |
| The Levels of Antinuclear Antibody (ANA) | ANA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Antimitochondrial Antibody (AMA) | AMA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Smooth Muscle Antibody (SMA) | SMA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Liver-Kidney Microsomal Antibody 1 (Anti-LKM1) | Anti-LKM1 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Soluble Liver Antigen / Liver-Pancreas Antigen (Anti-SLA/LP) | Anti-SLA/LP detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Neutrophil Cytoplasmic Antibody (ANCA) | ANCA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Glycoprotein 210 (Anti-gp210) | Anti-gp210 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Nuclear Pore Protein 100 (Anti-sp100) | Anti-sp100 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Antimitochondrial Antibody M2 (AMA-M2) | AMA-M2 detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Sjogren Syndrome B Antibody (Anti-SS-B) | Anti-SS-B detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| The Levels of Anti-Sjogren Syndrome A Antibody (Anti-SS-A) | Anti-SS-A detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer | Baseline, Weeks 12, 24, 36, 48 |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | 315000 | China |
|
| Ningbo Mingzhou Hospital (Affiliated to Zhejiang University) | Ningbo | Zhejiang | 315000 | China |
|
| Ningbo No.2 Hospital | Ningbo | Zhejiang | 315000 | China |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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