hR3 MAb in combination with chemo-embolization in hepatocellular carcinoma.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Toxicological evaluation and antitumoral effect of hR3 MAb in combination with chemo-embolization in hepatocellular carcinoma treatment.

Secondary indentifying numbers:

IIC RD-EC084

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

18/08/2006

Reference number:

1467/05.007.06B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Julio Cesar Hernandez, MD. 2nd degree Specialist in Internal Medicine.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Center of Researches Surgical-Medical (CIMEQ), January 30, 2006.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

02/01/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Hepatocellular carcinoma

Intervention(s):

The study will include 4 MaB dose levels, 3 patients at each level. Dose to be evaluated: hR3 50mg, 100mg, 200mg and 400mg. All patients will receive chemo-embolization and TheraCIM hR3 humanized monoclonal antibody. There will be one single MaB administration in combination with 5-Fluoracyl, Lipiodol, and Gel Foam by intra-arterial route.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Toxicity, measuring time: 9 months.

Key secondary outcomes:

Maximum Permissible Dose (MPD) or optimal biological dose, survival, duration of objective antitumoral response, and dose-effect relation, measuring time: 3 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

74 years

Inclusion criteria:

1) Patients with CHC diagnosed, eligible for chemo-embolization. 2) Capacity to understand the study and readiness to sign the informed consent document. 3) Patients with measurable lesions (in, at least, one dimension: greater diameter) using conventional techniques (CAT and US). 4) Age >= 18 years and under 75 years. 5) ECOG general health condition <= 2 (Karnofsky >= 60%,). 6) Mean life expectancy over 2 months. 7) Child- Pugh-Turcotte A or B functional stage. 8) OKUDA I or II staging system. 9) Patients with organs and bone marrow working well, in line with the following parameters: leukocytes: >= 2,000 x 109/l, hemoglobine: >= 9 g/dl, absolute neutrophil counting: >= 1,500/ul, platelet counting: >=50,000/ul, creatinine clearing: >= 60 mL/min/1.73m2 (For patients with creatinine values higher than normal, as established by the institution). Electrocardiogram: without alterations in auricularventricular conduction. 10) Female reproductive-age patients should be pregnancy-tested negative and use appropriate contraceptives such as IU devices, hormonal contraceptives, barrier methods or tubal ligation. Men should use contraceptives while on treatment. 11) Patients who have been successfully treated against skin carcinomas or in situ uterus carcinoma.

Exclusion criteria:

1) Terminally ill patients with life expectancy shorter than 1 month. 2) Cirrhotic patients in functional stage C according to Child-Pugh-Turcotte Classification. 3) Patients on other research product. 4) Patients with allergy history attributed to chemical or biological compounds similar to TheraCIM hR3 MAb or the chemotherapy used in the trial. 5) Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable angina pectoris, and mental or social diseases limiting adherence to clinical trial requirements. 6 As a result of potential and unknown adverse events in infants, breastfeeding women will not be included in the clinical trial. 7) Patients with previous malignant neoplasias, except those patients who have been on appropriate treatment for skin carcinomas or in situ uterus carcinomas. 8) Patients with extrahepatic metastasis. 9) Patients with hepatic encephalopathy. 10) Patients with biliary obstruction. 11) Patients with hepatofugal portal flow. 12) Tumor size exceeding liver size by 50 percent. 13) Patients with serum bilirubin over 40umol/l. 14) Patients with TGP over 100 UI/l.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Sequential

Phase:

1

Target sample size:

15

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000022

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2008-01-17 19:00

Link to the spanish version:

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Proceso de Registro

hR3 MAb in combination with chemo-embolization in hepatocellular carcinoma.

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