Upper Gastrointestinal, Pancreatic & Liver

The following list provides a brief description of upper gastrointestinal, pancreatic and liver cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 

DYNAMIC-Pancreas

Registered Title Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study (DYNAMIC- Pancreas)
 
Purpose Pancreatic cancer cells have DNA mutations that are not present in normal cells. For some people, cancer-specific DNA can be found circulating in their bloodstream after they had surgery to remove their pancreatic cancer. This tumour-specific DNA may be evidence that some cancer cells have escaped before the pancreatic cancer was removed. The DYNAMIC-Pancreas study aims to see whether a test called "circulating tumour DNA" can be used to decide the type and duration of post-surgery chemotherapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for localised pancreatic cancer and have been recommended adjuvant chemotherapy. You will still be eligible if you had neoadjuvant treatment prior to surgery.

Study Details.
All participants in this study will have blood drawn for circulating tumour DNA analysis during week 4-6 post-surgery, and throughout chemotherapy treatment (up to 3 times).
Participants that had neoadjuvant therapy prior to surgery, will be randomly allocated to one of two treatment groups, where the choice of chemotherapy regimen will be made prior to randomisation: One group will receive the standard of care treatment of modified FOLFIRINOX - a combination of fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin. The other group will have their treatment based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment.
Participants that did not have neoadjuvant therapy prior to surgery, will be placed in a separate, non-randomised group. All participants in this group will have their treatment selection based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment or a longer duration of the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment.
All patients will be followed up every 3 months for 2 years, then every 6 months up to year 5. Follow up includes blood tests and radiological assessments. It is hoped that this study will provide evidence that using a test to look for the presence or absence of circulating tumour DNA can help guide the type or duration of adjuvant chemotherapy used after pancreatic cancer surgery.. This test may reduce the number of patients that have detectable circulating tumour DNA after completing adjuvant chemotherapy, compared to standard of care treatment. This may in turn demonstrate that management of pancreatic cancer based on circulating tumour DNA results is superior to the current standard of care treatment."

Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
 Links  Australian New Zealand Clinical Trials Registry

Acknowledgement: Australian New Zealand Clinical Trials Registry

 

 

COMPETE

Registered Title A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)
 
Purpose  The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide
Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus
in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+),
neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Lay Summary  Lay Summary
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

OPS-C-001

Registered Title  An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
Purpose The purpose of this clinical phase I/II study is to investigate the safety and tolerability
of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs).
Secondary objectives of these study are the assessment of biodistribution, dosimetry and
preliminary efficacy of 177Lu-OPS201.
Lay Summary  N/A
WA Trial Sites

 GenesisCare WA

Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

 

EMERALD-2

Registered Title  A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Purpose  A global study to assess the efficacy and safety of durvalumab in combination with
bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high
risk of recurrence.
Lay Summary  N/A
WA Trial Sites  08 6151 1061
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

APOLLO

Registered Title A Phase 1/2 Dose Escalation and Expansion Study of Combination APL-501 or Nivolumab With APL-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma
Purpose  This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.
Lay Summary  N/A
WA Trial Links

Cancer Centre Clinical Trials Unit - Phone 08 615 26530

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

PARALLEL 303 BGB-290-303

Registered Title PARALLEL 303: A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy
Purpose  This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.
Lay Summary  N/A
WA Trial Sites   St John of God Subiaco    Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

ACTICCA-1 Gallbladder Carcinoma Study

Registered Title

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

Purpose

This is a multicentre, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo      SCGH Medical Oncology   Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

ALT GIST Study

Registered Title

A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST).

Purpose

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

Lay Summary

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

WA Trial Sites

Sir Charles Gairdner Hospital Logo        SCGH Medical Oncology    Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CONTROLNETS

Registered Title

 

 

A parallel group randomised, controlled, multi-centre phase II open label trial to evaluate progression free survival in Cohort A: Pancreatic NETs - peptide receptor radionuclide therapy (PRRT)/capecitabine + temozolomide (CAPTEM) vs. CAPTEM (control) and Cohort B: Midgut NETs - PRRT/CAPTEM vs. PRRT (control).

                                            
Purpose



The CONTROL NETS study aims to determine the activity of capecitabine + temozolomide (CAPTEM)/peptide receptor radionuclide therapy (PRRT), alone and in combination, in both pancreatic neuroendocrine tumours (pNETS) and mid-gut neuroendocrine tumours (mNETS) patients.

Lay Summary  N/A
WA trial Sites







Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links  US National LIbrary of Medicine


Acknowledgements: US National Library of Medicine

 

INTEGRATE II Gastro-Oesophageal Cancer Study

Registered Title

A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC).

Purpose

Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no established standard treatment following failure of first and second line chemotherapy. Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general aim of this study is to determine if regorafenib improves overall survival in refractory AGOC.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo    St John of God   Ph. (08) 6465 9204

Sir Charles Gairdner Hospital Logo   SCGH Medical Oncology    Ph. (08) 6383 3000

 

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

NABNEC AG0215NET

Registered Title   A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
       
Purpose Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a highly prevalent disease, responsive to a number of therapies, some of which are proven in modern randomised controlled trials, but many of which still require high quality clinical trial evidence to confirm their effectiveness and guide their use in practice. This study is the first prospective trial to evaluate modern combination chemotherapy. for comp.  
Lay Summary  N/A
Wa Trial Sites

Cancer Centre Clinical Trials Unit
Phone 08 615 26530 

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

TOPGEAR (TROG 08.08)

Registered Title

A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer.

Purpose

The primary objective is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response (pCR) rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1 dissection) for resectable gastric cancer.

Lay Summary

The optimal management of patients with resectable gastric cancer continues to evolve.  Chemotherapy regimes are better, radiation techniques have improved and there is an increasing interest in the use of chemoradiotherapy prior to surgery for gastric cancer.  The important question addressed in this trial is whether chemoradiation is better than chemotherapy alone in the treatment of resectable gastric cancer.

WA Trial Sites

 Sir Charles Gairdner Hospital logoSCGH Medical Oncology     Ph. (08) 6383 3000

Links

Trans-Tasman Radiation Oncology Group

Australian New Zealand Clinical Trials Registry

 

CEND1

Registered Title

A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer   
Purpose This is an open-label, multicenter, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of CEND-1 in combination with nabpaclitaxel and gemcitabine administered weekly for three weeks followed by one week off over 28 days.

This protocol is designed to evaluate the safety, tolerability, and biologic activity of CEND-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who are undergoing combination therapy with nabpaclitaxel and gemcitabine. CEND-1 is a tumor-penetrating peptide (scientifically also known as iRGD) that activates a drug transport mechanism specifically in tumors.

Study involves an initial dose escalation phase with three different CEND-1 dose levels, first as a monotherapy (during 1-week run-in), followed by combination therapy with nabpaclitaxel and gemcitabine (one 28-day treatment cycle). A subsequent expansion phase with approximately 28 subjects will assess the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels.

Lay Summary  N/A
WA Trial Sites

 St John of God - Subiaco (08) 6465 9204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

[Return to List of Clinical Trials]


Sequoia

Registered Title  Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
 
 Purpose  To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.
 WA Trial Sites

 Murdoch Clinical Trials Unit  9428 8556

 Lay Summary  N/A
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine