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).
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.
Up to three tumours, at least one with a diameter > 3cm
More than three tumours, none with a diameter > 5 cm
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)
Target Disease Exceptions
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Any evidence of tumour metastasis or co-existing malignant disease.
Participants showing evidence of macrovascular invasion on imaging tests.
National Cancer Centre, Singapore
Lead sponsor
Bristol-Myers Squibb
Collaborator