Personalized Cancer Vaccine in Egyptian Cancer Patients (NCT05059821) | Clinical Trial Compass
UnknownPhase 1
Personalized Cancer Vaccine in Egyptian Cancer Patients
Egypt10 participantsStarted 2021-04-19
Plain-language summary
Evaluate safety and immunogenicity of peptide cancer vaccine in patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection and refractory to the available institutional standard of care lines of treatment .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who developed recurrence of HCC after surgical resection .
. Age ≥ 18 years.
. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2 .
. Patient with radiologically or pathologically confirmed hepatocellular carcinoma.
. Patients who had been treated with surgical approach as per our (Ain Shams University) institute protocols and developed recurrence after surgery. They were either intolerant to the institute protocol of treatment or showed unresponsiveness of their disease after treatment.
. Child-Pugh class A or B .
. LAB values:
. Patient has not received any antineoplastic chemotherapy, immunotherapy, or radiotherapy for the four weeks prior to the start of study treatment.
Exclusion criteria
. Patients receiving continuous systemic steroid treatment within the last 4 weeks prior to start of study treatment (The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the safety of the personalized cancer vaccine
. Patients receiving systemic immunotherapy or immunosuppressant medication other than steroids within the last 4 weeks prior to start of study treatment.
. Patients with a history or evidence of systemic autoimmune disease.
. Active second malignancy or a prior malignancy within the past 12 months.
. Acute active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 1 week before the start of study treatment \[Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infections are permitted; direct-acting antivirals may be administered when medically indicated\].
. Any other acute medical condition that may compromise patient's safety or the activity of the studied vaccine treatment.
. Any other concurrent severe or uncontrolled chronic disease such as uncontrolled non-malignant liver, renal or lung disease, or decompensated cardiac failure or coronary insufficiency.
. Administration of a live, attenuated vaccine within 4 weeks before randomization