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

Colorectal Cancer Clinical Trial

Official title:
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)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04912765
Study type Interventional
Source National Cancer Centre, Singapore
Contact Si Lin Koo
Phone +65 6436 8000
Email koo.si.lin@singhealth.com.sg
Status Recruiting
Phase Phase 2
Start date April 15, 2021
Completion date May 2025
View Details
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