We are thrilled to share that two of our community-funded studies have now closed for recruitment: PALEO, an oesophageal cancer clinical trial, and PemOla, a pancreatic cancer clinical trial.
PALEO, oesophageal cancer trial
Led by Associate Professor Fiona Day and Professor Jarad Martin, this community-funded, Phase II trial is investigating whether a targeted combination of radiation, chemotherapy and immunotherapy can improve outcomes for people with advanced oesophageal cancer. Importantly, the trial aims not only to control cancer, but also to improve quality of life for patients who often face significant challenges with eating and swallowing.
For oesophageal cancer, patients are usually diagnosed at more advanced stages (as distinctive symptoms have developed) when curative options are not available. One of these distinctive symptoms is having difficulty swallowing, which affects the person’s ability to eat and drastically reduces their quality of life.
PALEO builds on promising results from an earlier Phase I study led by Associate Professor Day and Professor Martin, which demonstrated the treatment approach was safe and improved swallowing in all participating patients. The work was recognised with the Best Poster Award in GI Cancer Trials’ Best of the Best Session at the 2019 Annual Scientific Meeting.
Beyond cancer control, PALEO places a strong focus on quality of life. Food is a cultural expression for many people – not being able to enjoy food with family and friends is a major loss for many people struggling to find normalcy in a life post-diagnosis. By measuring quality-of-life outcomes alongside clinical outcomes, the trial aims to help patients live as well as possible for as long as possible.
“Not been able to swallow is a devastating symptom. Eating is such a basic and vital activity, and having that taken away has major consequences. For me as a clinician, it is important to manage symptoms like difficulty swallowing as well as the disease with treatments that are accessible and acceptable to patients.” – Associate Professor Fiona Day, Study Co-Chair
PALEO now moves into follow-up and data analysis, and we eagerly await the results.
“Reaching this milestone means a great deal to me, my team and our patients. Thank you to everyone involved in the trial, including the patients, families, clinicians, research teams and community supporters who helped make this study possible. We are incredibly grateful for the confidence you have shown in our work and remain committed to improving outcomes for people with oesophageal cancer.” – Professor Jarad Martin, Study Co-Chair
PemOla, pancreatic cancer trial
Led by Associate Professor Daniel Croagh and Associate Professor Sumitra Ananda, the PemOla trial, aims to understand whether patients with high tumour mutational burden (TMB) could respond well to a combination immunotherapy treatment. High TMB can be identified using biological samples from patients with metastatic pancreatic cancer. The trial was made possible thanks to community-funded grants and philanthropy.
“Reaching full recruitment is a significant milestone for the PemOla trial and the research team. It means the trial has successfully enrolled the number of patients needed to evaluate the treatment combination, allowing researchers to move forward with analysing the data and understanding whether this approach can benefit patients with high tumour mutational burden. It is also a testament to the dedication of the patients, families, clinicians and research team involved, as well as the generosity of the community whose support helped make the trial possible.” – Associate Professor Croagh, Study Co-Chair
In the search for more effective treatments, immunotherapy is increasingly being explored as an alternative to chemotherapy. Immunotherapy stimulates the patient’s own immune system to recognise and attack cancer cells.
Mutations can make tumours more visible to the immune system, potentially making them more responsive to this drug combination. The immunotherapy drug works to stimulate the body’s immune system to attack cancer cells, while the PARP inhibitor prevents them from repairing themselves.
“For patients with metastatic pancreatic cancer, PemOla could represent an important step towards more personalised treatment options. If this combination of immunotherapy and a PARP inhibitor proves effective in patients with high tumour mutational burden, it could provide a new treatment pathway for a group of patients who currently have limited options. The findings could also help drive further research internationally and ultimately improve outcomes for people living with pancreatic cancer.” – Associate Professor Ananda, Study Co-Chair
If successful, PemOla could provide the first evidence that immunotherapy is an effective treatment for metastatic pancreatic cancer, leading to further international research.
“I can’t thank the community enough for your support. If the PemOla trial is successful, this combination therapy could become part of the standard of care for pancreatic cancer patients and contribute to long term improvements in survival rates.” – Associate Professor Croagh, Study Co-Chair
Thank you to all patients and their families who participate in our trials, and to the community for supporting these important studies. The successful completion of recruitment for both PALEO and PemOla reflects the commitment of participants, research teams and supporters who have made these studies possible. We look forward to sharing the results and the impact of these community-funded trials in the future.
Led by Associate Professor Fiona Day and Professor Jarad Martin, the PALEO trial was coordinated by Calvary Mater Newcastle, Australia. The trial is generously supported by GI Cancer Trials philanthropy and the Gut Cancer Foundation, which helped fund sites in Aotearoa New Zealand.
PemOla is led by Dr Pippa Corrie and sponsored by Cambridge University Hospitals NHS Foundation Trust with support from the National Institute for Health and Care Research Cambridge Biomedical Research Centre in the UK. GI Cancer Trials is acting as the local sponsor and coordinating centre, and Associate Professor Daniel Croagh and Associate Professor Ananda are the local Study Co-Chairs. The trial is generously funded by a Tour de Cure grant, a PanKind Australian Pancreatic Cancer Foundation Limited Research Grant, an Epworth Medical Foundation Grant and GI Cancer Trials philanthropy.