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.

 

NAPOLI 3

Registered Title An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
Purpose The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Lay Summary  N/A
WA Trial Sites

 Cancer Centre Clinical Trials Unit  Ph. (08) 615 26530

St John of God Subiaco   Ph. (08) 6465 9204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA209-9DX

Registered Title A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation
Purpose  This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Lay Summary  N/A
WA Trial Sites   Medical Oncology  Ph. (08) 6383 3000
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

NuTide:121

Registered Title A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
Purpose  NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.
Lay Summary  N/A
WA Trial Sites

 Phone 08 615 26530

Phone (08) 6383 3000

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

IMbrave050

Registered Title   A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation 
 Purpose    This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
 Lay Summary   N/A
 WA Trial Sites  

Cancer Centre Clinical Trials Unit     ph. (08) 615 26530

 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

Ph. (08) 6383 3000 

(08) 9242 7640

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-020

Registered Title A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Lay Summary  N/A
WA Trial Sites

  Ph. 08 6382 5513

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

KEYNOTE-937

Registered Title A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
Purpose This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Lay Summary  N/A
WA Trial Sites   ph. (08)  92248055
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

COSMIC-312

Registered Title A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy
Purpose This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
Lay Summary  N/A
WA Trial Sites

 Medical Oncology Ph. 08 6383 3000.   Radiation Oncology   Ph.  08 6383 3204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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.
Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit  Ph.  (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  Ph. (08) 615 26530
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  ph. (08) 6151 1061
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    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    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 Ph. 08 615 26530

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   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   Ph.  (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 logo 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

  ph. (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