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Could a cancer drug help cure hepatitis b? new trial launches

NCT ID NCT06357806

Disease control Sponsor: Beijing 302 Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether adding a PD-1 antibody (sintilimab) and pegylated interferon to standard antiviral therapy can help people with chronic hepatitis B lose the hepatitis B surface antigen (HBsAg), a key step toward a functional cure. The trial will enroll 45 adults who have been on antivirals for at least a year and have low but detectable HBsAg levels. Researchers will monitor safety and how many participants clear HBsAg at 24 and 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sintilimab (PD-1 antibody) combined with pegylated interferon-α2b
What this could lead to
If successful, this combination could help more people with chronic hepatitis B achieve a functional cure, meaning the virus is suppressed without lifelong medication.
What could go wrong
This is a small, early pilot study with only 45 participants, so results may not apply broadly. The treatment can cause immune-related side effects, and it is not yet known if it will work better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 - 65 years old; 2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months); 3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening; 4. HBV DNA and HBeAg turn negative after NAs treatment; 5. HBsAg ranged 200-1000 IU/ml. Exclusion Criteria: 1. Cirrhosis; 2. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN; 3. History of or suspicion of hepatocellular carcinoma 4. Patients received interferon therapy within 12 months; 5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months; 6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; 7. Alcohol or drug abuse/dependence; 8. Investigator judges that the participants are not suitable for this study.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

Contacts and locations

Locations

  • the Fifth Medical Center, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.