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.
PURPLE Registry
| Registered Title | Pancreatic cancer: Understanding Routine Practice and Lifting End Results (PURPLE). A Prospective Pancreatic Cancer Clinical Registry |
| Purpose | This project is non-interventional registry of the treatment and outcomes of patients with pancreatic cancer managed at hospitals enrolled to participate in Australia. |
| Lay Summary | This registry will capture data on presentation and the disease course of pancreatic cancer, surgical interventions for primary and metastatic disease, prescription of systemic therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting. This project will collect clinical data using the already established data collection and analysis resources built up over the last 15 years in the Systems Biology & Personalised Medicine Division of the Walter & Eliza Hall Institute of medical research (WEHI). |
| WA Trial Sites |  Oncology Ph. 08 615 26530 |
| Links | Australian New Zealand Clinical Trials Registry |
Acknowledgement: Australian New Zealand Clinical Trials Registry
INTEGRATEIIb
| Registered 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
| Registered 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
| Registered 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
| Registered 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 |
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| 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 |
| Lay Summary | N/A |
| WA Trial Sites |  Ph. (08) 9242 7640
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| 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 |
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| 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 |
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| 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 |
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| 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
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Registered Title |
A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC). |
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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. |
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Lay Summary |
N/A |
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WA Trial Sites |
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Links |
St John of God Ph. (08) 6465 9204
Medical Oncology Ph. (08) 6383 3000Acknowledgements: US National Library of Medicine
