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

NCT04912765 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-23

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Neoantigen Dendritic Cell Vaccine

10 doses of the vaccine will be administered via intra-dermal injection concurrently with adjuvant nivolumab.

DRUG

Nivolumab

9 doses of 240mg IV nivolumab as a 30 minutes infusion will be administered in combination with NA DC vaccine starting from the second vaccine dose. Upon completion of 10 doses of NA DC vaccine, 480mg IV nivolumab will be administered as a 30 minutes infusion for a maximum of 9 doses.

Sponsors & Collaborators

Principal Investigators

  • Si Lin Koo · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Singapore

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912765 on ClinicalTrials.gov