Safety, immunogenicity and evidence of effect of vaccine candidate CIGB-247 in the treatment of hepatocellular carcinoma.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 sites20 target enrollmentFebruary 16, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular carcinoma
Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Enrollment: 20
Status: Not Yet Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 16, 2017

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.

•1\) Compliance with diagnostic criteria (established by histological study or non\-invasive criteria for the diagnosis of hepatocellular carcinoma in cirrhotic patients or with hepatitis B virus presenting liver lesions greater than 1 cm tumor: Injury greater than or equal to 1 Cm detected by multislice computed tomography or dynamic contrast\-enhanced nuclear magnetic resonance, which shows arterial hypervascularization and late portal or portal phase lavage).
•2\) Age between 18 \- 70 years, both inclusive.
•3\) Patients in stages B or C, according to BCLC (Barcelona Clinic Liver Cancer) staging.
•a) Patient with a life expectancy \= 6 months.
•b) Functional state according to ECOG \= 2\.
•4\) Patient with at least one measurable lesion, according to modified RECIST criteria (mRECIST), and RECIL (Response Evaluation Criteria in Cancer of the Liver).
•5\) Patient with stabilization or progressive disease at the time of inclusion in the study.
•6\) Voluntariness of the patient through the signing of informed consent.

•1\) Unknown primary tumor.
•2\) Patients who have received antiangiogenic treatment in the last three months.
•3\) Have received chemoradiotherapy in the last 4 weeks.
•4\) Major surgery in the last 28 days.
•5\) Referred immunosuppressive disease; Ingestion of immunosuppressive / immunomodulatory drugs.
•6\) Patient with cerebral metastasis.
•7\) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy).
•8\) History of autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and severe allergic history (urticaria, dermatitis, bronchitis and persistent bronchial asthma).
•9\) Moderate or severe systemic infections that interfere with patient assessment.
•10\) History of allergy to any ingredient in the vaccine under study.