Ondansetron for Reducing Liver Cancer Treatment Side Effects
The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities
Recruiting
Phase 2Interventional Study
Hepatocellular Carcinoma (HCC)IrAE
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
First Affiliated Hospital of Wenzhou Medical University · Other
Who this trial is looking for
This trial is looking for patients with liver cancer who are starting treatment. Participants will take ondansetron to see if it helps lessen side effects from their cancer therapy.
Are You a Good Fit for This Trial?
Rules you outSevere liver dysfunction
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with liver cancer.
I am planning to receive standard treatment for liver cancer.
My performance status is 0 to 2.
I expect to live for at least 12 weeks.
My blood tests meet required health standards.
I voluntarily agree to join this study.
I will cooperate with follow-up visits.
You may not be able to join if
I have taken ondansetron in the past 14 days.
I have an autoimmune disease.
I have used glucocorticoids or immunosuppressants in the past 14 days.
I have stopped immune therapy before due to side effects.
I have severe liver dysfunction.
I have a condition that contraindicates ondansetron.
I am allergic to ondansetron.
I am using drugs that seriously interact with ondansetron.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 + pembrolizuma…
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.
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.