Hepatocellular Carcinoma (HCC)Phase 2NCT07381634
The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities
A Phase 2 study testing ondansetron in people with Hepatocellular Carcinoma (HCC) and IrAE, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), IrAE
- What is being tested?
- ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 20 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years old, both male and female are acceptable.
- The imaging or pathological diagnosis is hepatocellular carcinoma;
- It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.
- ECOG score: 0 to 2 points;
- Expected survival period ≥12 weeks;
- 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;
- The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Who cannot join
- Those who have received treatment with ondansetron within 14 days;
- Patients with autoimmune diseases;
- Use of systemic glucocorticoids or other immunosuppressants within 14 days;
- Those who have previously discontinued ICI treatment due to irAEs;
- Those with severe liver dysfunction (Child-Pugh grade C);
- Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;
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- Patients allergic to ondansetron;
- Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;
- The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Gang Chen, 86+13616619566, chen.gang@wmu.edu.cn
About this study
Official title: The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial
This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma (HCC), IrAE
- Being tested
- ondansetron
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetronDrug
Ondansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron Group | Experimental | Standard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab:
Ondansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance.
Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded. Receives: Drug: ondansetron |
| Control Group | No intervention | Standard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of irAEs
To evaluate whether the prophylactic use of ondansetron can reduce the incidence of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
Measured: through study completion, an average of 1 year
The Severity of irAEs
To evaluate whether the prophylactic use of ondansetron can reduce the severity of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
ORR
Objective Response Rate，according to RECIST v1.1
Measured: through study completion, an average of 1 year
DCR
Disease Control Rate, according to RECIST v1.1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start30 Apr 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381634
- Sponsor's protocol ID
- KY2026-021
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07381634
- Acronym / sponsor ID
- KY2026-021
- Conditions
- Hepatocellular Carcinoma (HCC), IrAE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Group | Experimental | Drug: ondansetronStandard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab: Ondansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance. Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded. |
| Control Group | No intervention | –Standard treatment plan：For patients with hepatocellular carcinoma, the standard treatment plan for liver cancer is adopted, which specifically includes lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab Symptomatic treatments other than 5-HT3 receptor antagonists are permitted, and all concurrent medication situations should be recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 to 80 years old, both male and female are acceptable.
- The imaging or pathological diagnosis is hepatocellular carcinoma;
- It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.
- ECOG score: 0 to 2 points;
- Expected survival period ≥12 weeks;
Key exclusion criteria (9 listed)
- Those who have received treatment with ondansetron within 14 days;
- Patients with autoimmune diseases;
- Use of systemic glucocorticoids or other immunosuppressants within 14 days;
- Those who have previously discontinued ICI treatment due to irAEs;
- Those with severe liver dysfunction (Child-Pugh grade C);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetronOndansetron: Maintained at 8mg/qd, orally, until disease progression or intolerance. | Drug | Ondansetron Group |
Primary outcome
The incidence rate of irAEs
Time frame: through study completion, an average of 1 year
To evaluate whether the prophylactic use of ondansetron can reduce the incidence of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
The Severity of irAEs
Time frame: through study completion, an average of 1 year
To evaluate whether the prophylactic use of ondansetron can reduce the severity of immune-related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICI). The evaluation criteria mainly refer to the "2023 CSCO Guidelines for the Management of Toxicity Related to Immune Checkpoint Inhibitors", with a focus on the incidence of all grades of irAEs and the incidence of severe irAEs at grade 3 and above. The monitoring scope covers liver and kidney functions, blood routine, cardiac function (electrocardiogram, myocardial injury markers), endocrine function (thyroid function, etc.) and imaging manifestations of pneumonia.
2 secondary outcomes
ORR
Time frame: through study completion, an average of 1 year
DCR
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ondansetron in people with Hepatocellular Carcinoma (HCC) and IrAE, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of irAEs (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.