An interventional study of Combined Peg IFNα-2b treatment group in HBV-HCC and Unresectable Advanced HBV-related Liver Cancer, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
This study is a prospective, real-world study intended to evaluate the efficacy and safety of pegylated interferon alpha-2b (PegIntron®) combined with targeted immunotherapy in patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma.
This study intends to enroll 20 patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma who have previously undergone and are currently receiving nucleoside (nucleotide) analog therapy. Subjects who meet the inclusion and exclusion criteria after evaluation will receive Pegasys® combined with targeted immunotherapy. Both targeted therapy and PD-1 inhibitors will be selected based on actual clinical decision-making, using standard therapeutic drugs recommended by the CSCO guidelines. During the study, each 6 weeks will be defined as a treatment cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. Follow-up will be completed according to the protocol until the end of the study.
1,345 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.
This study's planned enrollment of 33 is below the median of 48 across 928 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 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.
For females of , a negative pregnancy test result must be obtained within one week prior to the first administration of the study drug.
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.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Combined Peg IFNα-2b treatment group
On the basis of conventional treatment, combined with Peg IFNα-2b
One-year progression-free survival after treatment
The proportion of patients who have not progressed or died from any cause within one year after the start of treatment.
Time frame: At 1 year
Overall Survival (OS)
From first dose of treatment to date of death due to any cause, assessed up to 36 months.
Time frame: From first dose of treatment to date of death due to any cause, assessed up to 36 months.
Objective Response Rate (ORR)
The best overall response, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. Confirmed response requires tumor shrinkage to be confirmed at least 4 weeks after the initial documentation of response.
Time frame: At the time of best overall response, assessed up to 24 months.
HBsAg level, magnitude of decrease from baseline, kinetics, negativity rate (<0.05 IU/mL), and seroconversion rate
The change from baseline in HBsAg level, including the magnitude of decrease, kinetics, the rate of negativity (\<0.05 IU/mL), and the rate of seroconversion.
Time frame: At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96
Disease Control Rate (DCR)
The best overall response, defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). For patients with SD, the response must be confirmed at least 12 weeks after the first dose of treatment.
Time frame: From baseline until the end of treatment or disease progression, assessed up to 24 months.
HBV DNA levels, magnitude of decrease from baseline, and proportion of subjects with undetectable levels (among HBV DNA-positive patients)
To evaluate HBV DNA levels, the magnitude of decrease from baseline, and the proportion of subjects with undetectable levels among HBV DNA-positive patients.
Time frame: At baseline, Week 12, Week 24, Week 48, and Week 96.
HBeAg levels, magnitude of decrease from baseline, seroconversion rate, and negativity rate (among HBeAg-positive patients)
To evaluate HBeAg levels, the magnitude of decrease from baseline, seroconversion rate, and negativity rate among HBeAg-positive patients.
Time frame: t baseline, Week 12, Week 24, Week 48, and Week 96.
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline
To evaluate the change in ECOG Performance Status Score from baseline.
Time frame: At baseline, Week 12, Week 24, Week 48, and Week 96.
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Mar 2028, 26 months after the start.
Of 149 non-industry interventional studies with no phase under Liver Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 82. This study's planned 26 months is below that.
Counting every sponsor, half of 168 studies reached it within 39 months; a quarter within 18 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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