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HPB Clinical Trials

(i) Pancreas cancer

Liverpool CR UK Trials Unit has led large CR UK-funded randomised phase III clinical trials for the NCRN portfolio including adjuvant (ESPAC-1, 3 and 4) and palliative (GemCap, Telovac, VIP) trials, with practice-changing results. These trials have furnished a large biorepository of well-annotated samples in the LEDDU GCLP biobank, which is currently being interrogated for novel biomarkers and genomic signatures predictive of treatment effect, which can uniquely be performed in the context of these large prospective randomised trials. We have also recently received CR UK funding to undertake a feasibility study of neo-adjuvant therapy strategies for borderline resectable pancreas cancers (ESPAC-5).

VIP is a randomised phase II trial investigating the addition of vandetanib to chemotherapy for advanced pancreas cancer as part of the NCRN –AZ combinations alliance. The regional HPB oncology clinic led by Palmer has recruited almost one-third of the 120 patients in this trial and the LEDDU GCLP facility is banking biological samples and leading the translational components of this study.

We are the only UK centre for a phase I dose-escalation study of a novel hedgehog pathway inhibitor (LDE225, Novartis) in combination with chemotherapy for advanced pancreas cancer.

(ii) Biliary tract cancers

In collaboration with Professor Juan Valle, Christie, we are leading a neo-adjuvant chemotherapy feasibility study for resectable cholangiocarcinomas coordinated through LEDDU.

(iii) Hepatocellular carcinoma

Palmer and Johnson co-designed (with Dr Tim Meyer, UCL) the NCRN randomised phase III TACE-2 trial investigating the addition of sorafenib/placebo to standard chemo-embolisation for patients with intermediate stage HCC. In collaboration with David Adams, Birmingham, Palmer has also received NIHR EME funding for a randomised trial of autologous DC vaccination in combination with TACE.

Palmer is Chief Investigator for the NCRN randomised study of the Boehringer-Ingelheim drug BIBF1120 as first line therapy for patients with advanced HCC.

We are collaborating with Prof Thorsten Hagemann (Barts and St Marys) on the CR UK NAC-funded phase I trial of a novel macrophage and liver-specific HDAC inhibitor, tefinostat, for patients with HCC and is contributing analysis of antigen-specific T-cell responses and the novel DILI biomarker panel.