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.

 

CheckMate 74W

Scientific Title  A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination with Trans-arterial ChemoEmbolization (TACE) in Patients with Intermediate-stage Hepatocellular Carcinoma (HCC)
Purpose  The purpose of this study is to compare effectiveness and safety of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer
Lay Summary   NA
WA Trial Sites   (oncology) Ph. 08 615 26530
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

INTEGRATEIIb

Scientific Title   A Randomised Phase III Open Label Study of Regorafenib + Nivolumab vs Standard Chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
Purpose  To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall
survival compared with current standard chemotherapy options in refractory AGOC.
Lay Summary   In the INTEGRATE study, regorafenib alone was shown to be effective in prolonging the progression-free period in people with AGOC following standard anti-cancer therapy (i.e. it delayed tumour growth), and demonstrated a potential benefit on long term survival. Recent research has shown the early results from this combination of regorafenib & nivolumab may improve outcomes for cancer patients. INTEGRATE IIb will investigate this effect further in a larger group of participants with AGOC
WA Trial Sites    Ph. (08) 6465 9204
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

PANOVA-3

Scientific Title   Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma
 Purpose  The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Lay Summary  NA
WA Trial Sites  Oncology Clinical Trials Unit  Ph. (08) 9428 8556
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

TOPGEAR

Scientific Title   Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma. A randomised II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer.
Purpose This study aims to evaluate whether the addition of pre-operative chemoradiotherapy to chemotherapy is superior to chemotherapy alone in patients undergoing surgery for resectable gastric cancer.
Lay Summary  N/A
WA Trial Summary  Medical Oncology Ph. (08) 6383 3000
 Links  Australian New Zealand Clinical Trials Registry

Acknowledgement: Australian New Zealand Clinical Trials Registry

 

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

 

SKYSCRAPER-07

Scientific Title This is a Phase III, randomized, double-blind, three-arm, global, multicenter, placebo-controlled study designed to evaluate the safety and efficacy of tiragolumab in combination with
atezolizumab compared with placebo in patients with unresectable locally advanced esophageal
squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and who
have completed definitive concurrent chemoradiation therapy.
Purpose  N/A
 Lay Summary  N/a
WA Trial Sites  Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

ORIENT-15

Registered Title   A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)
 Purpose  This is a randomized, double-blind multi-center, phase III study comparing the efficacy and
safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in
subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell
carcinoma.
 Lay Summary  N/A
 WA Trial Sites

  Ph. (08) 6383 3000

Ph. (08) 6465 9204

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

LEAP-012

Registered Title  A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Purpose   The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and 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

 

PROOF

Registered Title A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Purpose  Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
(FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
The purpose of the study is to evaluate the efficacy and safety of the investigational agent
oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line
treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma
with FGFR2 gene fusions/translocations. Subjects will be randomized 2:1 to receive
infigratinib or gemcitabine plus cisplatin.
Lay Summary  N/A
WA Trial Sites   Ph. (08) 6465 9204
Summary  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 is an open-label Phase 1/2 study to assess the safety and tolerability of combination
PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor
(APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain
preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not
been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive
the combination APL-501 plus APL-101 while RCC subjects will receive the combination
nivolumab plus APL-101.

Lay Summary  N/A
WA Trial Sites Ph. (08) 9242 7640

Ph. 08 615 26530

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

 

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

 

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

 

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

 

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

 

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