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Can an immunotherapy drug keep liver cancer at bay after surgery?

NCT ID NCT03859128

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether toripalimab, an immunotherapy drug, can help prevent liver cancer from returning after surgery. Participants are people with hepatocellular carcinoma who have a high risk of recurrence despite having had the tumor completely removed. Half will receive toripalimab and half a placebo, and the study will compare how long they remain free of cancer recurrence.

What this could mean

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

Active substance
toripalimab (an immunotherapy drug that helps the immune system fight cancer)
What this could lead to
If successful, this could offer a new way to delay or prevent liver cancer from coming back after surgery, potentially improving long-term outcomes.
What could go wrong
This is a mid-to-late-stage trial, but results are not guaranteed. The drug may not improve recurrence-free survival, and immunotherapy can cause immune-related side effects.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

427 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Dec 2027

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 75 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. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection; 2. BICR confirmed no resdual tumor lesions are detected in liver; 3. Child-Puch score, Class A; 4. ECOG score is 0; Exclusion Criteria: 1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study; 2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer; 3. With symptoms of central nervous system metastasis; 4. With any history of active autoimmune disease or autoimmune disease; 5. Known liver diseases with clinical significance; 6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV): Other protocol defined inclusion/exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

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

Hepatocellular carcinoma

Contacts and locations

Locations

  • Zhongshan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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