Hepatocellular CarcinomaPhase 1PROVENCT05059821
Personalized Cancer Vaccine in Egyptian Cancer Patients
A Phase 1 study testing Peptide cancer vaccine in people with Hepatocellular Carcinoma, run by zeinab ahmed yousif hasan ashour at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Peptide cancer vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2021to Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
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- LAB values:
- Hemoglobin (≥ 8 g/dl), platelets (≥ 50,000/µl), leukocytes (≥ 2,500/µl), neutrophils (≥ 1,000/µl), lymphocytes (≥ 500/µl) Liver function: serum bilirubin (< 3 x ULN), Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (< 5 x ULN) Renal function: serum creatinine (< 1.5 x ULN)
- Patient has not received any antineoplastic chemotherapy, immunotherapy, or radiotherapy for the four weeks prior to the start of study treatment.
- Pregnancy test should be negative at the first dose of study treatment in fertile females. (Female patients who are not post-menopausal or surgically sterile should use a highly effective method of birth control from the date of signing the consent to the last follow up visit. Pregnancy test should be negative at the first dose of study treatment.)
- Written informed consent .
Who cannot join
- 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.
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- 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
- Known previous major hypersensitivity reactions.
- History of human immunodeficiency virus (HIV)
- Evidence of current alcohol or drug abuse
- Women who are pregnant or who are breast feeding
- Medical or mental impairments that may limit participation in the study as judged by the investigators disease specialist.
- History of organ allograft.
- History of splenectomy.
- Psychiatric illness or known social situation that would preclude study compliance.
- Encephalopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, 11566
Fatma Ebeid, MD, 01095569596, dr.fatma_ebeid@yahoo.com
Manal El-Sayed, MD, manalhelsayed@yahoo.co.uk
About this study
Official title: Phase I Clinical Trial of Alfa-Fetoprotein,Glypican-3 Based Personalized Cancer Vaccine in Egyptian Patients With Hepatocellular Carcinoma: Pilot Study
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 .
Read the detailed description
Ten patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection are refractory to the available institutional standard of care lines of treatment will be recruited to received the peptide cancer vaccine.
Tumour antigen peptides will be identified and separated from each patient and then reinjected with an adjuvant (autologous activated monocytes with autologous tumour derived heat shock protein 70) by subcutaneous route monthly for 6 months preceded by 300 mg cyclophosphamide one week before start of the vaccine.
A follow up for all cases will be performed clinically, laboratorial, and immunologically for one year.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Peptide cancer vaccine
- Keywords
- Peptide vaccine, Heat shock protein 70, Monocytes
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide cancer vaccineBiological
Vaccine content are personalized peptides vaccine separated from each patients own tumor cells, autologous heat shock protein 70 separated from tumor cells and autologous activated monocytes that administered subcutaneously monthly for six months
| Study group | Role | What they receive |
|---|---|---|
| Experimental Personalized Cancer Vaccine | Experimental | Patients with recurrent HCC after surgical resection and refractory to available line of treatment will receive Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes Receives: Biological: Peptide cancer vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of the personalized cancer vaccine
Percentage of patients who developed adverse events (AEs)
Measured: 4 weeks
Assessment of immunological response
Percentage of change in CD20 +B-cells, CD16+CD56+NK cells,CD4 + cells,CD8+ cells,CD25+regulatory cells
Measured: 12 weeks
Secondary outcomes (1)
Progression free survival and overall survival time
Progression free survival (PFS) time and overall survival (OS)time will be analysed using the Kaplan-Meier estimation method and log-rank test.
Measured: 144 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start19 Apr 2021
- Primary completionApr 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zeinab ahmed yousif hasan ashour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zeinab ahmed yousif hasan ashour, Ain Shams University
- Investigators
- Zeinab A Ashour, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059821
- Sponsor's protocol ID
- FMASU P109g/2019-2021
- Acronym
- PROVE
- Status last verified
- Aug 2022
- First submitted
- 11 May 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Alfa-Fetoprotein,Glypican-3 Based Personalized Cancer Vaccine in Egyptian Patients With Hepatocellular Carcinoma: Pilot Study
- ClinicalTrials.gov ID
- NCT05059821
- Acronym / sponsor ID
- PROVE / FMASU P109g/2019-2021
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Peptide vaccine, Heat shock protein 70, Monocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- zeinab ahmed yousif hasan ashourUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Ten patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection are refractory to the available institutional standard of care lines of treatment will be recruited to received the peptide cancer vaccine.
Tumour antigen peptides will be identified and separated from each patient and then reinjected with an adjuvant (autologous activated monocytes with autologous tumour derived heat shock protein 70) by subcutaneous route monthly for 6 months preceded by 300 mg cyclophosphamide one week before start of the vaccine.
A follow up for all cases will be performed clinically, laboratorial, and immunologically for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes
| Arm | Type | Receives |
|---|---|---|
| Experimental Personalized Cancer Vaccine | Experimental | Biological: Peptide cancer vaccinePatients with recurrent HCC after surgical resection and refractory to available line of treatment will receive Personalized peptide based vaccine with autologous heat shock protein 70 and autologous activated monocytes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide cancer vaccineVaccine content are personalized peptides vaccine separated from each patients own tumor cells, autologous heat shock protein 70 separated from tumor cells and autologous activated monocytes that administered subcutaneously monthly for six months | Biological | Experimental Personalized Cancer Vaccine |
Primary outcome
Assessment of the safety of the personalized cancer vaccine
Time frame: 4 weeks
Percentage of patients who developed adverse events (AEs)
Assessment of immunological response
Time frame: 12 weeks
Percentage of change in CD20 +B-cells, CD16+CD56+NK cells,CD4 + cells,CD8+ cells,CD25+regulatory cells
1 secondary outcome
Progression free survival and overall survival time
Time frame: 144 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab A Ashour, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peptide cancer vaccine in people with Hepatocellular Carcinoma, run by zeinab ahmed yousif hasan ashour at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab A Ashour, MD (01096056735, zeinabashour2012@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety of the personalized cancer vaccine (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.