CENTAURO-6 Study

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000237
• Date of registration: 16/02/2017
• Prospective Registration: Yes
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: CENTAURO-6 Study
• Scientific title: Safety, immunogenicity and evidence of effect of vaccine candidate CIGB-247 in the treatment of hepatocellular carcinoma.
• Date of first enrolment: 03/04/2017
• Target sample size: 20
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000237-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
• Phase: 1-2

Countries of recruitment

Cuba

Contacts

• Name: Francisco Hernandez Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Julio Cesar Hernandez Perera
• Affiliation: Center for Surgical Medical Research

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 70 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Neoplasms, Glandular and Epithelial

Carcinoma, Hepatocellular

Liver Diseases

Digestive System Neoplasms

Hepatocellular carcinoma

Adenocarcinoma

Digestive System Diseases

Carcinoma

Liver Neoplasms

Intervention(s)

Antigens

CIGB-247,
Vaccine anti-VEGF,
p64K-hVEGFKDR Antigens,
Adjuvant NAcGM3/VSSP Adjuvants,
Adjuvant Aluminum Phosphate

Gangliosides

Proteolipids

Adjuvants, Immunologic

Vaccines

Group I (experimental): Antigen p64K-hVEGFKDR-(800 µg) + NAcGM3s / synthetic VSSP (200 µg) applied subcutaneously in the deltoid region. The first 8 weeks, the subjects will receive an immunization every week. Then, the subjects will receive re-immunizations every 28 days for 24 months.
Group II (experimental): Antigen p64K-hVEGFKDR-(800 µg) + Aluminum phosphate (0.7 mg AL3 +) applied subcutaneously in the deltoid region. The first 8 weeks, the subjects will receive an immunization every 14 days. Then, the subjects will receive re-immunizations every 28 days for 24 months.

Injections, Subcutaneous

N-Acetylneuraminic Acid

G(M3) Ganglioside

Immunotherapy, Active

Vascular Endothelial Growth Factors

Primary Outcome(s)

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

Secondary Outcome(s)

Tumor evolution (modified RECIST criteria -mRECIST- and, -RECIL- Response Evaluation Criteria in Cancer of the Liver): Measurement time: 12 and 24 months.
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.
Laboratory (numerical values of hematological and biochemical tests). Measurement time: at baseline and, at weeks 13, 25, 49 and 73.
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.
Cellular immune response (ELISPOT for interferon gamma: average number of spots). Measurement time: At week 49.
Quality of life (EORTC survey QLQ-C30). Measurement time: at baseline and, months 12 and 24.

Secondary ID(s)

IG/CIGB-247I/TS/1606

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable