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Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

An Open Label, Single-arm, Phase II Neoantigen (NA) Dendritic Cell (DC) Vaccine and Anti-PD1 (Nivolumab) as Adjuvant Treatment in Resected Hepatocellular Carcinoma (HCC) (Group A) and Liver Metastases From Colorectal Cancer (CRLM) (Group B)

NCT04912765•National Cancer Centre, Singapore

View on ClinicalTrials.gov

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).

Detailed Description

Participants will be consented prior to resection of HCC and CRLM. Genomic sequencing of patient's blood and resected tumour will be performed, followed by tumour NA prediction and production. Patients will undergo venesection to generate DCs which will be pulsed with autologous NAs to produce the vaccine. 10 dose of intra-dermal NA DC vaccine will be administered every 2 weeks together with IV nivolumab (starting from the second vaccine dose). Patients will subsequently continue on adjuvant nivolumab to complete 1 year of treatment. Efficacy will be evaluated based on relapse-free survival (RFS) at 24 months from surgery and the analyses of specific anti-NA immune responses of autologous peripheral T cells by ELISPOT and/or ICS assays. Safety data will also be obtained for patients who have received at least one dose of treatment.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HCC specific criteria (Group A):
•Participants must have either newly diagnosed or recurrent HCC, confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic subjects amenable for management with curative intent by resection (with or without the addition of local ablation), if they fulfil the following radiological criteria.
•1. Up to three tumours, at least one with a diameter \> 3cm
•2. More than three tumours, none with a diameter \> 5 cm
•3. 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)
•Child-Pugh Score 5 or 6
•All participants are required to have imaging studies (CT chest, tri-phasic CT/MRI of the liver, contrast-enhanced CT/MRI of abdomen and pelvis and other suspected/known sites of disease, and bone scans if indicated) confirming no-extra-hepatic metastatic disease within 12 weeks prior to study enrolment.
•CRLM specific criteria (Group B):
•Patients with histologically- or cytologically-diagnosed colorectal cancer with liver-limited metastases are eligible to enrol if:
•1. 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
+50 more criteria

Exclusion Criteria

•HCC specific criteria (Group A):
•Target Disease Exceptions
•1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
•2. Any evidence of tumour metastasis or co-existing malignant disease.
•3. Participants showing evidence of macrovascular invasion on imaging tests.
•4. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
•5. Participants previously receiving any prior systemic therapy, trans-arterial embolization or chemoembolisation (TAE/TACE), selective internal radiation therapy (SIRT) and stereotactic radiation therapy (SBRT) for HCC.
•CRLM specific criteria (Group B)
•Target Disease Exceptions a) Patients with extra-hepatic colorectal metastases.
•1. Prisoners or participants who are involuntarily incarcerated.
+1 more criteria

Locations (1)

National Cancer Center Singapore

Singapore, Singapore

Key Dates

Start Date

April 15, 2021

Primary Completion Date

December 1, 2026

Completion Date

June 1, 2027

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatocellular CarcinomaHepatocellular CancerColorectal CancerColorectal CarcinomaLiver Metastases

Interventions

Neoantigen Dendritic Cell Vaccine

BIOLOGICAL

Nivolumab

DRUG

Contacts

Si Lin Koo

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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