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 range18 Years

SexALL

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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)
✕. 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

What they're measuring

Assessment of the safety of the personalized cancer vaccine

Timeframe: 4 weeks

Assessment of immunological response

Timeframe: 12 weeks

Trial details

NCT IDNCT05059821

Sponsorzeinab ahmed yousif hasan ashour

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04

Contact for this trial

Zeinab A Ashour, MD

01096056735 zeinabashour2012@yahoo.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials