CompletedPhase 2

Study of Y90-Radioembolization With Nivolumab in Asians With Hepatocellular Carcinoma

Singapore40 participantsStarted 2016-12-20

Plain-language summary

The purpose of this study is to evaluate the effect of liver-localised radioembolization and nivolumab on liver cancer.

Who can participate

Age range

21 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with hepatocellular carcinoma (HCC) that is not suitable for resection or liver transplant, who are planned for Y90 radioembolization as per institutional practice.
. Patients must have measurable disease with target lesion in liver, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
. Diagnosis of HCC confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic subjects. Patients without cirrhosis require histological confirmation of diagnosis
. No prior Y90 radioembolization therapy. Prior local therapies, such as surgery, hepatic artery embolization/chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoabalastion is allowed, if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan
. Age ≥ 21 years.
. ECOG performance status ≤ 2
. Life expectancy of greater than 3 months
. Only patients with Child-Pugh score for liver cirrhosis of A (sum of scores for five parameters: 5-6) will be allowed into this trial

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response Rate

Timeframe: Tumour assessment at 8 weeks

Trial details

NCT IDNCT03033446

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More HepatoCellular Carcinoma trials