In short
Clinical trials are studying Alizapride as part of cancer research in adults with solid tumours. The main goal is to see whether blood immune markers can help predict immune-related toxicities during checkpoint inhibitor treatment, while also tracking safety. This trial is a phase 2 interventional study.
Key points
- One authorised phase 2 trial is studying Alizapride in the setting of cancer care for people with solid tumours. The main focus is not on treating the cancer itself, but on finding blood immune markers that may help predict immune-related toxicities during checkpoint inhibitor treatment. Researchers will measure changes in serum autoantibody levels at early, middle, and late points in treatment, and again when these toxicities occur. Safety is also being tracked through reported adverse events using the CTCAE system. The study plans to enroll 441 participants.
Trial overview
The available trial on Alizapride is an interventional study, which means the research team is following people during a planned treatment setting and measuring outcomes over time. It is a phase 2 trial and is listed as Authorised. The study plans to enroll 441 participants.
The main goal is to explore whether blood immune markers can help identify biomarkers for immune-related toxicities linked to checkpoint inhibitor treatment. A biomarker is a measurable sign in the body that may help predict or track a disease or treatment effect.
Who is being studied
This trial includes cancer patients with a solid tumour. A solid tumour is a cancer that forms a mass in an organ or tissue, rather than a blood cancer.
The source data do not provide more detailed inclusion or exclusion rules, so only the broad target population can be described from the trial record.
What the researchers are measuring
The primary outcome is the change in immune blood markers, including serum autoantibody levels, at three time points during checkpoint inhibitor treatment: early, mid time, and late. The same markers are also measured when immune-related adverse events occur.
In simple terms, the team is checking whether blood tests change over time and whether those changes are linked to side effects from treatment. This may help doctors in the future understand which patients are more likely to develop toxicity during immunotherapy.
Trial design and treatment context
The study is focused on checkpoint inhibitor therapy in cancer patients. The intervention list contains many cancer medicines, including Alizapride, but the source data do not explain a direct treatment role for each listed drug within the study record.
The brief summary says the study is a pilot project. A pilot study is an early research project used to explore whether a larger idea is worth studying further.
Safety assessment
Safety will be assessed by investigators using reported adverse events and the CTCAE system, which stands for Common Terminology Criteria for Adverse Events. This system is a standard way to describe and grade side effects in clinical trials.
The safety assessment is important because the study is looking at immune-related toxicities during checkpoint inhibitor treatment. In this context, the researchers are not only looking for blood marker changes, but also checking how often and how severely side effects happen.
Key points for patients
- The study is about cancer patients with solid tumours who are receiving checkpoint inhibitor treatment.
- The main research question is whether blood immune markers can help predict toxicity during treatment.
- Researchers are checking serum autoantibody levels at several points during treatment and when side effects appear.
- The trial is phase 2, authorised, and plans to include 441 people.
- Safety is tracked with reported adverse events using the CTCAE grading system.