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.

 

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

 

MM-398-07-02-03
A Phase 2 Metastatic Pancreatic Cancer Trial

Registered Title

A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma.

Purpose

This is an open-label, phase 2 comparative study to assess the safety, tolerability, and efficacy of nal-IRI in combination with other anticancer therapies, compared to nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy.

Lay Summary

N/A

WA Trial Sites

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

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine


ARTIST

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 AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by overall survival
 Lay Summary  N/A
 WA Trial Sites

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.au

 Links  US National Library of Medicine

Acknowledgements US National Library of Medicine

 

CanStem111P

Registered Title     A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
         
 Purpose  This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
 Lay Summary  N/A
 WA Trial Sites

        SCGH Medical Oncology   Ph. (08) 6383 3000  

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Checkmate-577

Registered Title


A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer.    
 Purpose              The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.
 Lay Summary  N/A
 WA Trial Sites

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539

oncologytrials.murdoch@sjog.org.au

 Links  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
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

 

SIRCCA Study

Registered Title

Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma.

Purpose

The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

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

 

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

 

I3Y-MC-JPCJ

Registered Title  An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
 Purpose The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
      
Lay Summary  
 N/A
 WA Trial Sites

SCGH Medical Oncology    Ph. (08) 6383 3000

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

 

 

Checkmate-649

Registered Title  A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Purpose  N/A
Lay Summary  N/A
WA Trial Sites

 

Murdoch Oncology Clinical Trials Unit (08) 9428 8556

 Links  US National Library of Medicine

 

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