An Early Phase 1 interventional study of Peginterferon alfa-2b and TDF in Hepatocellular Carcinoma, HEPATITIS B CHRONIC and Hepatitis B Chronic Infection, sponsored by Ningbo No.2 Hospital. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Ningbo No.2 Hospital · Early Phase 1, Interventional, and Treatment
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:
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 156 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Ningbo No.2 Hospital is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF/TAF/TMF)
Drug: Peginterferon alfa-2b · Drug: TDF · Drug: TAF · Drug: TMF
Patients receive first-line nucleos(t)ide analogues (TDF/TAF/TMF) alone
Drug: TDF · Drug: TAF · Drug: TMF
Concentration of Hepatitis B Surface Antigen (Hepatitis B Surface Antigen, HBsAg)
Serum HBsAg concentration assessed by Chemiluminescent Microparticle Immunoassay (CMIA). Unit: IU/mL
Time frame: 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
Time frame: 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
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
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
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, 216, 240
Concentration of Hepatitis B e Antigen (HBeAg)
Serum HBeAg concentration assessed by CMIA. Unit: S/CO
Time frame: 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
Time frame: 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
Time frame: Years 1, 2, 3, 5
Overall survival (OS)
Time from enrollment to death from any cause, regardless of the cause of death. Unit: Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 24, Week 48
The Levels of Thyroid Stimulating Hormone (TSH)
TSH measured by chemiluminescent immunoassay (CLIA). Unit: mIU/L
Time frame: Baseline, Weeks 12, 24, 36, 48
The Levels of Free Triiodothyronine (FT3)
FT3 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L
Time frame: Baseline, Weeks 12, 24, 36, 48
The Levels of Free Thyroxine (FT4)
FT4 measured by chemiluminescent immunoassay (CLIA). Unit: pmol/L
Time frame: Baseline, Weeks 12, 24, 36, 48
The Levels of Thyroglobulin Antibody (TgAb)
TgAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL
Time frame: Baseline, Weeks 12, 24, 36, 48
The Levels of Thyroid Peroxidase Antibody (TPOAb)
TPOAb measured by chemiluminescent immunoassay (CLIA). Unit: IU/mL
Time frame: Baseline, Weeks 12, 24, 36, 48
Concentration of Alpha-fetoprotein (AFP)
AFP measured by CLIA. Unit: ng/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Weeks 12, 24, 36, 48
The Levels of Antimitochondrial Antibody (AMA)
AMA detected by indirect immunofluorescence assay (IFA). Unit: Positive or Negative; Titer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Weeks 12, 24, 36, 48
Plan to share: No — IPD sharing is not planned for this investigator-initiated study. Data will be used only for the primary study analysis and reporting.
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Dec 2034, 105 months later.
Of 145 non-industry phase 1 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 80. This study's planned 105 months is above that.
Counting every sponsor, half of 248 studies reached it within 49 months; a quarter within 32 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Peginterferon alfa-2b
Ningbo No.2 Hospital