- The primary liver cancer hepatocellular carcinoma (HCC) is the third most common cause of cancer deaths in males and fifth most common cause in females in Singapore.
- Led by the National Cancer Centre Singapore the investigator-initiated, phase 2 clinical trial, across 13 sites in the APAC region, will assess a novel radiotherapy and immunotherapy combination to treat HCC.
- This trial is supported by SG$19.2 million in industry funding from Roche and Sirtex, with additional in-kind contributions to improve clinical practice and outcomes for HCC patients.
Singapore, 29 September 2022 – A multi-national, investigator-initiated and industry-backed clinical trial was launched to test the efficacy of a novel radiotherapy and immunotherapy combination that aims to improve health outcomes for patients with the primary liver cancer, hepatocellular carcinoma (HCC). Led by the National Cancer Centre Singapore (NCCS), the AHCC09 (STRATUM) study has received SGD19.2 million in funding from industry partners Roche and Sirtex and will be conducted across 13 sites in the Asia Pacific region.
Liver cancer is the sixth most common cancer in the world and fourth most common cause of cancer deaths globally.[1] In Singapore, it is the third most common cause of cancer deaths in males and fifth most common cause in females[2]. Up to a third of patients in the Asia Pacific region present with intermediate stage HCC at diagnosis, making it the biggest sub-group of HCC patients. Intermediate stage HCC is heterogeneous and hard to treat, thus creating an urgent need to seek more effective treatments and improve outcomes for patients.
Building on past breakthroughs
Current standard-of-care for intermediate stage HCC is local delivery of chemotherapy to the tumour using a procedure called embolisation (TACE), or radiation delivery via blood vessels directly to the tumour, in a procedure called Yttrium-90 radioembolisation (Y90-RE). In recent years, immunotherapy has been used to treat HCC with promising results. However, only a subset of HCC patients, around 30%, respond to immunotherapy.
Research previously conducted by a NCCS team showed that Y90-RE boosted immune cells with anti-tumour activity and potentially enhance the efficacy of immunotherapy for HCC patients. Building on those findings, the same team has launched AHCC09 (STRATUM) to compare the safety and efficacy of Y90-RE followed by the immunotherapy atezolizumab and bevacizumab. This will be compared against a control group with Y90-RE followed by a placebo. Atezolizumab and bevacizumab are immunotherapies that are currently approved to treat HCC along with a number of other cancers.
The double blind, placebo-controlled, Phase 2 clinical trial aims to enrol 176 patients with intermediate stage HCC across 13 sites in Singapore, China, Taiwan and South Korea. Starting in October 2022, the study will run for two years and one month, with data analysis conducted at 12 months and 18 months to evaluate early efficacy and safety of the treatment combination, and follow-up analysis after the study’s completion to evaluate long-term efficacy and safety.
“Liver cancer is a challenging cancer to treat and this is especially so for intermediate stage liver cancer and in those with invasion of blood vessels. By building on our earlier translational discoveries, we aim to find more targeted and efficient treatment for liver cancer to improve treatment outcomes and increase tumour response,” said Professor Pierce Chow, lead investigator of the study and Senior Consultant, Department of Hepato-Pancreato-Biliary and Transplant Surgery, Division of Surgery and Surgical Oncology, Singapore General Hospital and NCCS.
Industry backing reflects Singapore’s standing as a biomedical research hub
The trial is supported by SGD19.2 million in funding from Roche and Sirtex, as well as by in-kind contributions for therapeutics and devices, marking a significant commitment from industry for an investigator-initiated research study.
“The strong industry support for AHCC09 (STRATUM) validates national efforts to establish Singapore as a vibrant biomedical research hub, that is differentiated by an integrated network of scientists and clinician-scientists who work closely with industry to deliver impactful research,” said Professor Tan Say Beng, Executive Director, Singapore Ministry of Health’s National Medical Research Council.
"Roche is committed to tackling liver disease, through all stages, with the ultimate goal of bringing innovative interventions earlier in the disease,” said Dr Sivabalan Sivanesan, Medical Director at Roche Singapore. "Atezolizumab in combination with bevacizumab is currently approved for front line treatment of advanced HCC. We are excited to be part of this collaboration, and we look forward to seeing how combining immunotherapy with other treatments can improve outcomes of patients with intermediate stage HCC."
“The delivery of effective treatment begins with research, which is why we at Sirtex recognise the importance of setting research up for success,” Kevin R. Smith, Chief Executive Officer of Sirtex. “Our team is proud to be collaborating with the National Cancer Centre Singapore on the ACHCC09 (STRATUM) study, and we look forward to its future developments.”
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About the National Cancer Centre of Singapore
The National Cancer Centre Singapore (NCCS) is a leading national and regional tertiary cancer centre with specialists who are experts in treating cancer. NCCS attends to the majority of cancer cases in Singapore’s public healthcare sector. In addition to offering holistic and multidisciplinary oncology care, our clinicians and scientists collaborate with local and international partners to conduct robust, cutting-edge clinical and translational research. To achieve the vision of being a global leading cancer centre, NCCS offers world class care and shares its depth of experience and expertise by training local and overseas medical professionals.
To meet growing needs, the new NCCS building will be completed in 2022 with increased capacity and expanded facilities dedicated to cancer care, rehabilitation, research and education. To give patients the best treatment outcomes, NCCS will offer access to advanced and innovative treatment such as proton therapy at the new Goh Cheng Liang Proton Therapy Centre.
For more information, please visit: www.nccs.com.sg
For more information, please contact:
National Cancer Centre Singapore
Dharshini Subbiah
Assistant Manager, Corporate Communications
Mobile : 9616 7532
Email : dharshini.subbiah@nccs.com.sg
[1] Singal, A. G., Lampertico, P. & Nahon, P. Epidemiology and surveillance for hepatocellular carcinoma: New trends. J. Hepatol. 72, 250–261 (2020)
[2] National Registry of Diseases Office. (2022, Jan). Singapore Cancer Registry Annual Report 2019.