Clinical trial · Interventional
Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed
A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the safety and efficacy of TroVax in patients undergoing surgical resection of colorectal cancer with liver metastases. TroVax potentially works by encouraging the immune system to react against the 5T4 protein on the surface of bowel cancer cells. The immune system is then able to recognise 5T4 and kill cells that carry it. The hope is that if tumour cells started to grow again after the main tumour has been surgically removed, the immune system would be able to find and destroy them.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TroVax | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To characterise and quantify the immune response to the oncofetal antigen 5T4 locally in peripheral blood, modified by vaccination with TroVax before resection of colorectal adenocarcinoma liver metastases.
- measure
- To evaluate the safety, toxicity and tolerability of the TroVax vaccine in this setting.
Secondary outcomes (3)
- measure
- To characterise and quantify the immune response to the oncofetal antigen 5T4 locally in tumour.
- measure
- To review any further effect on immunity by TroVax vaccinations following surgery.
- measure
- To monitor and collect data on clinical outcomes (time to progression/relapse/death).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Colorectal adenocarcinoma with metastases confined only to the liver, histologically proven and considered suitable for treatment by surgical resection. * World Health Organisation (WHO) performance status of 0 or 1 * All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient. Exclusion Criteria: * Radiotherapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the trial. * Patients who are high medical risks because of non-malignant systemic disease, including those with active uncontrolled infection. * Concurrent serious infections within the 28 days prior to entry to the trial * Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. * Patients known to be serologically positive for Hepatitis B, C or HIV * History of allergy to vaccinations or egg proteins. * Inflammatory bowel disease * History of autoimmune disease * Clinical evidence of cerebral metastases
References
Publications (0)
Data not yet available