RecruitingPhase 2

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

Singapore60 participantsStarted 2021-04-15

Plain-language summary

This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with/without local ablation).

Who can participate

Age range

21 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

. Up to three tumours, at least one with a diameter \> 3cm
. More than three tumours, none with a diameter \> 5 cm
. Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)
. There are no other sites of metastases aside from the liver confirmed by imaging studies (contrast-enhanced CT chest, abdomen and pelvis or contrast-enhanced CT chest and MRI abdomen and pelvis and other suspected sites of disease, and bone scans if indicated) at least 12 weeks prior to study enrolment AND
. The liver metastases are amenable and planned for curative surgical resection with or without the addition of local ablation AND
. The primary colorectal tumour had previously been resected or is amendable and planned for surgical resection.

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

24-month Relapse Free Survival

Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years

Induced immune response against vaccinated NAs

Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years

Trial details

NCT IDNCT04912765

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Si Lin Koo

+65 6436 8000 koo.si.lin@singhealth.com.sg

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Who can participate

Age range

21 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

. Up to three tumours, at least one with a diameter \> 3cm
. More than three tumours, none with a diameter \> 5 cm
. Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)
. There are no other sites of metastases aside from the liver confirmed by imaging studies (contrast-enhanced CT chest, abdomen and pelvis or contrast-enhanced CT chest and MRI abdomen and pelvis and other suspected sites of disease, and bone scans if indicated) at least 12 weeks prior to study enrolment AND
. The liver metastases are amenable and planned for curative surgical resection with or without the addition of local ablation AND
. The primary colorectal tumour had previously been resected or is amendable and planned for surgical resection.

What they're measuring

24-month Relapse Free Survival

Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years

Induced immune response against vaccinated NAs

Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria