Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
Trial Parameters
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Brief 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).
Eligibility Criteria
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 enrolm