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Common nausea pill may tame immunotherapy's harsh side effects in liver cancer

NCT ID NCT07381634

Symptom relief Sponsor: First Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests whether ondansetron, a drug typically used for nausea, can lower the risk and severity of side effects from immunotherapy in people with liver cancer. About 134 patients will receive ondansetron alongside their standard cancer treatment. The goal is to see if this approach makes immunotherapy safer without reducing its effectiveness.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 134 people

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

Started

Apr 2026

Expected to finish

Jun 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 80 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. Age: 18 to 80 years old, both male and female are acceptable. 2. The imaging or pathological diagnosis is hepatocellular carcinoma; 3. It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab. 4. ECOG score: 0 to 2 points; 5. Expected survival period ≥12 weeks; 6. Baseline blood cell count tests and blood biochemistry must meet the following standards: White blood cell count ≥3.0×10\^9/L; Hemoglobin ≥90 g/L; The absolute neutrophil count is ≥1.5×10\^9/L; Platelet count ≥100×10\^9/L; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin ≤ twice ULN; Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g/L; 7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up. Exclusion Criteria: 1. Those who have received treatment with ondansetron within 14 days; 2. Patients with autoimmune diseases; 3. Use of systemic glucocorticoids or other immunosuppressants within 14 days; 4. Those who have previously discontinued ICI treatment due to irAEs; 5. Those with severe liver dysfunction (Child-Pugh grade C); 6. Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria; 7. Patients allergic to ondansetron; 8. Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine; 9. The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma immune reconstitution inflammatory syndrome

As listed by the trial registrant

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

Hepatocellular carcinoma (HCC) IRAE

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

More trials for these conditions

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