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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000022
• Date of registration: 29/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: hR3 MAb in combination with chemo-embolization in hepatocellular carcinoma.
• Scientific title: Toxicological evaluation and antitumoral effect of hR3 MAb in combination with chemo-embolization in hepatocellular carcinoma treatment.
• Date of first enrolment: 02/01/2007
• Target sample size: 15
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000022-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Sequential

Countries of recruitment

Cuba

Contacts

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 74 years
Gender: Both

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.

Primary Outcome(s)

Toxicity, measuring time: 9 months.

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC084

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable