CENTAURO-6 Study

Phase 1

Conditions: Hepatocellular carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial

Registration Number: RPCEC00000237

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.
11) Patient pregnant or breastfeeding.
12) Obvious mental inability to issue consent and act accordingly with the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (Time from randomization until death from any cause). Measurement time: weekly during the first 8 weeks) and, later, monthly for two years. <br>Time to radiological progression (Time since patient recruitment until objective tumor progression). Measurement time: 12 and 24 months.<br>

Secondary Outcome Measures

Name	Time	Method
Tumor evolution (modified RECIST criteria -mRECIST- and, -RECIL- Response Evaluation Criteria in Cancer of the Liver): Measurement time: 12 and 24 months. <br>Adverse clinical events-AE (occurrence of AE (Yes, No) Description of AE (event name) Intensity of AE (mild, moderate, severe)). Measurement time: at baseline, weekly in during the first 8 immunizations, and thereafter with a monthly frequency throughout the study period. <br>Laboratory (numerical values of hematological and biochemical tests). Measurement time: at baseline and, at weeks 13, 25, 49 and 73. <br>Humoral immune response (determination of anti-VEGF antibody titers; percent inhibition - VEGF binding and its receptor). Measurement time: At weeks 13, 25, 49 and 73. <br>Cellular immune response (ELISPOT for interferon gamma: average number of spots). Measurement time: At week 49. <br>Quality of life (EORTC survey QLQ-C30). Measurement time: at baseline and, months 12 and 24.