Personalized Cancer Vaccine in Egyptian Cancer Patients

Hepatocellular Carcinoma Clinical Trial

— PROVE  

Official title:

Phase I Clinical Trial of Alfa-Fetoprotein,Glypican-3 Based Personalized Cancer Vaccine in Egyptian Patients With Hepatocellular Carcinoma: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059821
• Other study ID #: FMASU P109g/2019-2021
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2021
• Est. completion date: August 2024

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Zeinab A Ashour, MD
• Phone: 01096056735
• Email: zeinabashour2012[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who developed recurrence of HCC after surgical resection .

2. Age = 18 years.

3. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2 .

4. Patient with radiologically or pathologically confirmed hepatocellular carcinoma.

5. 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.

6. Child-Pugh class A or B .

7. 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)

8. Patient has not received any antineoplastic chemotherapy, immunotherapy, or radiotherapy for the four weeks prior to the start of study treatment.

9. 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.)

10. Written informed consent .

Exclusion Criteria:

1. 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)

2. Patients receiving systemic immunotherapy or immunosuppressant medication other than steroids within the last 4 weeks prior to start of study treatment.

3. Patients with a history or evidence of systemic autoimmune disease.

4. Active second malignancy or a prior malignancy within the past 12 months.

5. 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].

6. Any other acute medical condition that may compromise patient's safety or the activity of the studied vaccine treatment.

7. 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.

8. Administration of a live, attenuated vaccine within 4 weeks before randomization

9. Known previous major hypersensitivity reactions.

10. History of human immunodeficiency virus (HIV)

11. Evidence of current alcohol or drug abuse

12. Women who are pregnant or who are breast feeding

13. Medical or mental impairments that may limit participation in the study as judged by the investigators disease specialist.

14. History of organ allograft.

15. History of splenectomy.

16. Psychiatric illness or known social situation that would preclude study compliance.

17. Encephalopathy.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• Peptide cancer vaccine
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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
zeinab ahmed yousif hasan ashour

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety of the personalized cancer vaccine	Percentage of patients who developed adverse events (AEs)	4 weeks
Primary	Assessment of immunological response	Percentage of change in CD20 +B-cells, CD16+CD56+NK cells,CD4 + cells,CD8+ cells,CD25+regulatory cells	12 weeks
Secondary	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.	144 week