Concepts in Development

The AGITG research development strategy and prioritisation framework outline the process by which concepts progress from embryonic ideas to funded trials. The concepts listed below have been identified as a research priority for AGITG by the Working Parties, Community Advisory Panel and Scientific Advisory Committee, and are currently seeking funds to commence the trial.

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ABC-HCC

TUMOUR: Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the main form of primary liver cancer and is increasing in Australia. The outcomes for HCC remain poor, with less than 1 in 5 people surviving beyond 5 years after diagnosis and ranks as the second most deadly cancer globally. The management of HCC is complex, particularly as the major risk factor for developing HCC is advanced scarring of the liver, termed cirrhosis. The current standard treatment for those with intermediate stage HCC who cannot have curative treatments is a radiological procedure called transarterial chemoembolization (TACE). TACE works by giving small doses of chemotherapy directly into liver cancers and simultaneously blocking the blood supply to the cancer. TACE has variable outcomes and cancer recurrence occurs in approximately 1 in 3 patients. Recently, a combination of two medications has improved outcomes in patients with advanced stage HCC. One of the medications is an immunotherapy drug (atezolizumab), where the patient’s own immune system is stimulated to attack liver cancer cells, and the other medication in the combination (bevacizumab) alters cancer bloods vessels.

Atezolizumab/bevacizumab has become the standard of care for advanced HCC, however, the use of this combination in intermediate stage HCC has not been studied. This study aims to find out if atezolizumab/bevacizumab treatment is better than TACE, which is the current standard of care for intermediate stage HCC.

REGATTA

TUMOUR: Metastatic Colorectal Cancer

Metastatic colorectal cancer (mCRC) is a form of cancer that has spread from the colon or rectum to other parts of the body. Despite advances in treatment, the prognosis for patients with refractory mCRC remains poor, and new therapeutic strategies are urgently needed.

The REGATTA study aims to evaluate the efficacy of combining regorafenib with aspirin in patients with mCRC who have not responded to standard treatments. Pre-clinical studies have shown promising results, indicating an effect between regorafenib and aspirin in colorectal cancer models. This combination could potentially improve outcomes for patients with advanced mCRC.

This Phase 2b randomised, placebo-controlled trial will compare the combination treatment of regorafenib, capecitabine and aspirin to regorafenib, capecitabine and placebo. The study will enrol 58 patients across multiple sites in Australia over an 18-month timeframe. The primary endpoint is the 6-month progression-free survival rate, with secondary endpoints including toxicity, quality of life, and overall response rates.

The REGATTA study, chaired by Dr. Matt Burge, with co-chairs Prof. Vicki Whitehall and Dr. Mark Nalder, is sponsored by AGITG. The central coordination vendor is pending selection. Translational research samples will be stored and analysed at the Whitehall Laboratory, QIMR Berghofer Medical Research Institute.

By investigating this novel combination therapy, the REGATTA trial hopes to provide new insights and improve the management of refractory mCRC.

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