Trials


Pancreatic Service

The Professorial Hepatopancreatobiliary Unit at the Royal Liverpool University Hospital is the largest national centre for pancreatic diseases in the UK. The Professorial Unit accepts primary, secondary and tertiary referrals from centres across the UK and worldwide.

The Professorial Hepatopancreatobiliary Unit is led by prominent academics from the University of Liverpool, Professors John Neoptolemos and Robert Sutton. The clinical team, in support of Professors Neoptolemos and Sutton, are led by two Senior Clinical Lecturers; Mr Christopher Halloran and Miss Paula Ghaneh.

RS_Scientists

This has led to the foundation of a strong base of research into pancreatic disease in Liverpool, with the capacity to run surgical/drug clinical trials and research into protein derived and genetic markers under the auspices of the academic unit, Liverpool Cancer Trials Unit and Liverpool Experimental Cancer Medicines Centre through our large patient base and internationally renowned academic record (e.g. ESPAC-1, ESPAC-3 and ESPAC-4 clinical trials). 

Both Professors, Senior Clinical Lecturers and a Hepatopancreatobiliary Consultant Surgeon, Mr Michael Raraty, lead the NHS service. The senior surgical team are supported by a large pancreatic medical team comprising of: two Clinical Registrars, two Senior House Officers, a Hepatopancreatobiliary MacMillan Specialist Nurse, additional senior specialist nurses and excellent ward staff. The pancreas service is supported by the Royal Liverpool University NHS Trust Department of Gastroenterology and Radiology, who provide leading diagnostic and therapeutic services including: EUS, CT, PET-CT and MRI. Senior medical staff from the Gastroenterology, Radiology, Oncology and Pathology services join the Professorial surgical team to form the Regional Hepatopancreatobiliary Multi-Disciplinary Team (MDT). The MDT is supported by two MDT co-ordinators and accepts referrals from across the North West plus other UK and worldwide centres. The Professorial Unit is supported in the provision of cancer care by Clatterbridge Centre for Oncology (CCO).

 

Clinical trial/study portfolio

EUROPAC

The PBRU administers the European Registry for Hereditary Pancreatitis and Familial Pancreatic Cancer (EUROPAC). EUROPAC has been running since 1997 and has 249 families with pancreatitis (723 affected individuals). It has been shown that patients with hereditary pancreatitis have a 40% lifetime risk of developing pancreatic cancer. Also, EUROPAC has registered 168 families with more than 1 case of pancreatic cancer. We are analysing epidemiological and genetic factors which may contribute towards the development of pancreatic cancer in high risk families, which may help explain the aetiology of pancreatic cancer and provide new approaches for diagnosis and treatment of the disease. EUROPAC

 

 

EUROPAC-2
European Registry of Hereditary Pancreatitis and Familial Pancreatic Cancer (EUROPAC)2 trial to investigate the efficacy of antioxidants and magnesium for the treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis.

Both Hereditary and idiopathic Chronic Pancreatitis present early in childhood, with clearly defined episodes of pancreatic pain. Both conditions have a high risk for the development of complications of pancreatitis and ultimately pancreatic cancer. A targeted, low toxicity treatment administrated early in disease progression is desirable, both to reduce the number of exacerbations and potentially modify disease progressions.


The role of antioxidants in symptom modifications in Hereditary Pancreatitis has not been evaluated by a randomised controlled trial, although a number of studies suggest that they may be beneficial. The usefulness of magnesium therapy has been demonstrated in an animal model of acute pancreatitis. Regardless of whether magnesium was administrated as a prophylactic or therapeutic infusion it reduced the premature intrapancreatic activation of digestive proteases in the pancreas and had a beneficial effect on the course of experimental pancreatitis.
 

This trial is now open.  Please contact the Europac Team on 0151 706 4168 or by e-mail at EUROPAC@liv.ac.uk

Information is also available on their website.

EUROPAC_2

 

 

TeloVac
This study now in follow-up.  It was designed as a prospective, phase III, controlled, open label, multicentre, randomised clinical trial comparing combination Gemcitabine and Capecitabine therapy with concurrent and sequential immunotherapy using the telomerase vaccine GV1001
Telomerase is a ribonucleoprotein enzyme which is involved in the DNA replication of the cell cycle. The enzyme is over-expressed in majority of human cancers including 90% of advanced pancreatic cancer patients and therefore is a natural therapeutic target in the treatment of cancer.

The over-expression of Telomerase enables the cancer cells to overcome mortality and therefore be a major contributing factor to progression of cancer. Telomerase is one of the body's own proteins and therefore not recognised or attacked by the immune response. The GV1001 vaccine targets the over-expressed telomerase by enabling the immune response to recognise the enzyme and illicit an immune response against it. As telomerase is over expressed in majority of cancers and plays a leading role in the mortality of cancer cells, GV1001 could in future become a common cancer vaccine.

The trial was recently highlighted on 14th April 2011 by the BBC on the 6 o'clock and 10 o'clock News, and also on Radio 4 and 5-Live.   Professor John Neoptolemos and patients were interviewed at the Royal Liverpool University Hospital.  Further details can be found at the links below, courtesy of the BBC's Medical Correspondant, Fergus Walsh
 
Please click here for the to the BBC website with video link to the interview.
 
Please click here for the link to the BBC for information regarding the trial. 
 

ESPAC-3 (V2)
European Study Group for Pancreatic Cancer (ESPAC) Trial 3 (v2). Adjuvant Chemotherapies in Resectable Pancreatic Cancer.

Pancreatic cancer is one of the major causes of cancer death in Central and Northern European countries as well as in North America, Australasia and Japan 1. Initial treatment involves surgical resection Despite recent improvements in resection rates for localised pancreatic cancer, long-term survival following surgery alone remains poor with a median of 11-15 months, 2-year survival of 20-40% and 5-year survival of around 10% 2, 3. ESPAC-3 was formulated as a result of the ESPAC-1 study.

Pancreatic tumours are highly characterised in molecular terms facilitating molecular taxonomy of these tumours and the identification of predictive therapeutic response molecular signatures. ESPAC-3 trial is now comparing adjuvant 5-FU and gemcitabine.


ESPAC-4
EUROPEAN STUDY GROUP FOR PANCREATIC CANCER (ESPAC) -Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer.
Long term survival following resection for pancreatic cancer still needs to be improved. Adjuvant 5-FU/FA demonstrates significant improvement in overall survival following surgery, adjuvant gemcitabine demonstrates a survival advantage following surgical resection for pancreatic cancer. Gemcitabine plus capecitabine improves survival in patients with advanced pancreatic cancer compared with single agent gemcitabine.

ESPACT+
The ESPAC-1 trial has shown that pancreatic ductal adenocarcinoma is responsive to adjuvant chemotherapy (5FU). The ESPAC-1 trial has shown that pancreatic ductal adenocarcinoma is responsive to adjuvant chemotherapy (5FU). The ESPAC-3 trial is now comparing adjuvant 5-FU and gemcitabine.

ESPAC-TPlus was funded by the Translational Research in Clinical Trials Committee (TRICC) of Cancer Research UK in order to enable high quality translational research to be embedded in the ESPAC trials. ESPAC-TPlus is designed to allow both prospective and retrospective sample collection and analysis.


Bilcap
A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone following surgery for biliary tract cancer.

Pfizer
An Open-Label Sunitinib Malate (SU011248) Continuation Protocol for Patients who have Completed a Prior Sunitinib Study and are Judged by the Investigator to Have the Potential to Benefit from Sunitinib Treatment (Pfizer A6181114).

Merck PN144
To evaluate PET-CT imaging for monitoring chemotherapy response in pancreatic cancer (Merck PN144).

PET-Panc
Multi-centre prospective diagnostic accuracy and clinical value study of PET-CT in suspected pancreatic malignancy

Secretin stimulated endoscopic collection of duodenal aspirate for the analysis of molecular markers for the early detection of pancreatic cancer
To validate a technique of pancreatic juice collection, which will prevent exposure to the risk of ERCP pancreatitis by avoiding pancreatic duct cannulation.

Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head – A randomized controlled multicentre trial (ChroPac)
To investigate differences in Quality of Life (QoL) during 24 months after surgery
of duodenum-preserving pancreatic head resection (DPPHR) versus
pancreatico-duodenctomy (PD).

DISPACT
A randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy (DISPACT).

PanGen-EU
The objectives of the PanGen –EU study is to:
1) assess the environmental and genetic risk factors responsible for sporadic pancreatic cancer,
2) to identify families with an aggregation of relatives suffering from pancreatic cancer,
3) to act as a repository of biological samples and clinical information for the MOLDIAG EU Consortium.