Chemoradiation With Enadenotucirev as a Radiosensitiser in Locally Advanced Rectal Cancer
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
The use of chemoradiotherapy (CRT), in combination with surgery is the standard of care in
the treatment of locally advanced rectal cancer. However some patients don't respond well to
radiation.
More advanced radiotherapy techniques, that result in fewer toxicities, means that we are now
able to combine new anti-cancer agents into standard treatment. Targeting the tumour early in
this way has the potential to improve response rates.
Enadenotucirev is a specific type of anti-cancer virus that only targets cancer cells. It
acts in the same way as any virus and can only survive by replicating inside cancer cells and
not normal, non-cancerous cells. This means that it can selectively target and destroy
tumours, without directly affecting normal cells. It also has the ability to attract cells
from the body's immune system to help fight the cancer.
The addition of enadenotucirev to standard chemoradiotherapy treatment may have a combined
effect on the cancer cells with potentially few, additional side effects.
This trial aims to determine the optimal dose and frequency of the virus to give by gradually
increasing the number of doses each successive patient receives, and then increasing the dose
of the virus itself. Each patient will receive a minimum of 3 doses, up to a maximum of 8,
spread over the course of their 5 week standard chemoradiotherapy treatment. Patients will be
closely monitored at all times to ensure that with each dosing group, there aren't excessive
side effects.
Patients will then undergo surgery as part of their standard of care and be followed up for
up to 24 months to determine the long term effects of this treatment.
This trial aims to determine the optimal dose and frequency that can then be used in future
studies with the possibility of exploring the addition of Enadenotucirev to other
chemoradiotherapy treatments.