OncoMatch/Clinical Trials/NCT04912765
Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
Is NCT04912765 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Neoantigen Dendritic Cell Vaccine and Nivolumab for hepatocellular carcinoma.
Treatment: Neoantigen Dendritic Cell Vaccine · Nivolumab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Hepatocellular Carcinoma
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: peri-operative chemotherapy — CRLM
Participants must have received peri-operative chemotherapy or are being planned for adjuvant chemotherapy after curative surgical resection
Cannot have received: systemic therapy
Participants previously receiving any prior systemic therapy...for HCC
Cannot have received: trans-arterial embolization or chemoembolisation (TAE/TACE)
Participants previously receiving any prior...trans-arterial embolization or chemoembolisation (TAE/TACE)...for HCC
Cannot have received: selective internal radiation therapy (SIRT)
Participants previously receiving any prior...selective internal radiation therapy (SIRT)...for HCC
Cannot have received: stereotactic radiation therapy (SBRT)
Participants previously receiving any prior...stereotactic radiation therapy (SBRT)...for HCC
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: anti-PD-L1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: anti-PD-L2 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: anti-CTLA-4 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: IFN-based therapy
Participants receiving or expected to receive IFN-based therapies during the study period
Lab requirements
Blood counts
WBC ≥ 2,000/μL (stable, off any growth factor within 4 weeks); Neutrophils Absolute ≥ 1,500/μL (stable, off any growth factor within 4 weeks); Hemoglobin ≥ 8.5 g/dL (may be transfused); Platelet count ≥ 60 × 10^3/μL (transfusion not permitted)
Kidney function
serum creatinine of < 1.5 × ULN or a creatinine clearance > 40 mL/min (Cockcroft-Gault formula)
Liver function
Serum albumin > 2.8 g/L (transfusion to meet this level is not permitted); Serum total bilirubin < 3 mg/dL; AST and ALT ≤ 5 × ULN
Screening laboratory values must meet the following criteria... Adequate hematologic function... Adequate hepatic function... Adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04912765 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy, trans-arterial embolization or chemoembolisation (TAE/TACE), selective internal radiation therapy (SIRT) disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify