ANZCTR search results

This multi-site Phase I/Ib open-label study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ACS2015, a non-viral gene-modified CAR-T cell therapy, in adults with advanced solid tumors expressing EPHB4. Who is it for? You may be eligible to join this study if you are aged 18 to 70 years and have a histologically confirmed advanced solid tumor (such as colorectal cancer, hepatocellular carcinoma, or bone/soft tissue sarcoma) where at least 1% of tumor cells are positive for EPHB4. Additional eligibility criteria include good performance status (ECOG 0–1), suitable venous access, and measurable disease. Study details: The study will be conducted in two parts: • Phase I (Dose Escalation): Up to 36 participants (12 per tumor type) will receive ACS2015 at increasing dose levels using a staggered 3+3 design to determine the maximum tolerated dose (MTD). • Phase Ib (Dose Expansion): Up to 12 additional participants (4 per tumor type) will receive ACS2015 at the highest safe dose identified. Participants will first undergo pre-screening to confirm EPHB4 expression using tumor tissue. If eligible, they will proceed to screening and apheresis to collect peripheral blood mononuclear cells (PBMCs), which will be used to manufacture ACS2015. After lymphodepletion over 3 days, ACS2015 will be administered as a single infusion on Day It is hoped that this research will provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives, by targeting EPHB4 with a novel CAR-T cell therapy designed to reduce immune exhaustion and improve durability compared to conventional approaches.

This single-arm pilot feasibility study will evaluate the OA Champions Peer Mentorship Program for people with knee osteoarthritis. The program offers up to six one-to-one sessions between a trained Mentor and matched Mentee, delivered over a 12-week period. The overarching aim is to assess feasibility, acceptability and satisfaction, participant feedback, and preliminary clinical outcomes, as reported by both Mentors and Mentees.

A recent trial (ACTRN12622000113752) with 89 participants demonstrated the efficacy and safety of an online group-based therapy for people with chronic pain, Pain and Emotion Therapy plus TAU (PaET plus TAU). Results showed significant improvements in emotion dysregulation and provided preliminary evidence for a significant reduction in pain severity, depression, anxiety, stress, sleep problems and improved wellbeing (Norman-Nott et al., 2025). The aim of the current randomised controlled trial is to evaluate the efficacy of Pain and Emotion Therapy+ plus TAU, with an additional module on pain and movement education added to the program to reduce pain severity. Secondary aims include evaluating the effects on pain disability, emotion dysregulation, depressive symptoms, anxiety symptoms, sleep quality, level of physical activity, resilience, post-traumatic stress disorder symptoms, suicide cognitions and quality of life.

This project explores new, more accessible ways for people in rural areas to complete a standard heart health check. The feasibility of two new modes of delivery will be evaluated. The at home mode of delivery enables participants to self-administer a heart health check using a returnable kit. The local pharmacy mode of delivery enables participants to receive a hearth health check at their local pharmacy facilitated by the pharmacist using the same kit. Heart Health Check assessments are communicated to participants by post, and optionally by phone. The assessment advice received recommends participants who are evaluated as intermediate and high risk follow up with a GP and bring the assessment letter to their visit. The two new modes of Heart Health Check Delivery are referred to as models of care in the study protocol below. Participants who are not selected onto the Heart Health Check Study Population will be put on to a Heart Health Check Waitlist.

Disasters can disrupt childhood development and increase the long-term risk of mental health difficulties. Although most children and adolescents recover with appropriate support, evidence for effective interventions to protect youth mental health in disasters remains limited. This study aims to evaluate the effectiveness of Psychological First Aid in Schools (PFA-S), a school-based training program designed to prepare primary and secondary school staff to support student wellbeing during and after disasters and critical incidents. This study will provide important evidence for an accessible, scalable school-based intervention to strengthen staff capacity to provide psychosocial support to students in disasters, promoting recovery and preventing long-term psychological impacts.

Inherited bleeding disorders are most commonly due to coagulation factor deficiency. While bleeding disorders like haemophilia are readily diagnosed, patients with inherited abnormalities in platelet number and function often remain undiagnosed for prolonged periods. This project provides a diagnostic platform to provide a specific genetic diagnosis to these individuals and families with a bleeding disorder allowing better management of their symptoms and allowing rational prescribing of blood products. The consumer representative identified accuracy of diagnosis and quality of life as the most important issues.

This trial aims to determine changes in the control of breathing in the supine posture (lying flat on your back), with bronchodilator therapy and ventilatory support and the link with breathing discomfort and sleep in people with chronic obstructive pulmonary disease. Non-invasive recordings of brain activity, termed electroencephalography, will be used to determine changes in the control of breathing that occur with change from seated to supine posture, after bronchodilator therapy and after ventilatory support via a face mask. The link between changes in the control of breathing with breathing discomfort during these conditions (assessed by questionnaire) and sleep quality (assessed by an under-mattress sensor and sleep diaries). Baseline lung function and questionnaire responses will be collected.

Pathological production of polyols after brain injury may be a cause for secondary neurological injury. Polyols are osmotic and neurotoxic, which may have detrimental outcomes for critically ill individuals with brain injury. This study will be a biospecimen analysis of cerebrospinal fluid in health volunteers, aiming to quantify polyol concentrations. The results will act as a control group to compare with populations studied in other trials investigating polyol production in ICU patients with traumatic brain injury, subarachnoid haemorrhage, and pain conditions.

This study aims to compare rates of complications, dwell time and treatment completion with midclavicular catheters and peripherally inserted central catheters (PICCs). We hypothesize that in adults, midclavicular catheters (MCCs) will be associated with lower rates of complications compared with PICCs, similar rates of treatment completion, and similar dwell time.

Vasoactive drugs are amongst the most commonly prescribed medications for critically ill adult patients in intensive care units (ICU). Noradrenaline is the universally recommended first-line agent for such patients but questions remain around the timing of commencing additional (adjunctive) vasoactive medications, such as vasopressin. This study will determine whether a large-scale stepped wedge trial implementing and evaluating a strategy of using vasopressin as an early adjunctive vasopressor in the ICU is feasible. We will also collect provisional data on the physiological effects, efficacy and safety of early adjunctive vasopressin in adults receiving vasopressors in the ICU.