Liver Cell Carcinoma Non-resectable Clinical Trial
Official title:
Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh
in women and is the third most common cause of death from cancer worldwide. The overall
incidence of HCC remains high in developing countries and is steadily rising in most
industrialized countries.
TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy
option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were
developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence
within the tumor. The comparison of efficacy and safety of TACE with drug-eluting
microspheres in comparison with conventional TACE (cTACE) showed that response and time to
progression in the group was significantly higher than that of the cTACE group. TACE with
drug-eluting microspheres thus appears to be a feasible and promising approach to the
treatment of HCC.
This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using
drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using
drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Study Design: Prospective observational study . Primary objective: To collect data on tumor
response after administration of drug-eluting microspheres that were preloaded with
doxorubicin.
Secondary objectives: To collect data on survival rate, time to progression, tolerability of
treatment, number of treatment required to achieve objective response and improvement of
quality of life.
Treatment method:
Day -1 Doxorubicin at a dose of 35/50 mg/m2 has been charged onto 2 ml of microspheres at
Pharmacy. It is suggested to dissolve Doxorubicin powder with 2 ml of contrast medium. The
charging time of microspheres is at least 30 minutes.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme
appropriate for analgesic prophylaxis (3-day duration) as previously reported (17)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of
physiological solution) and 1 vial of morphine hydrochloride diluted in 100 ml i.v. are
administered by slow drip.
One vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the
procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication (optional) with 1 vial of verapamil
diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Tumor Infusion (segment/s with dominant disease) of Doxorubicin at a dose of 35/50 mg/m2
preloaded into 2 ml of 70-150 µm M1 microspheres.
A second tumor infusion is allowed if other lesions are present (daughter tumor), using
Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres
(following radiologist and oncologist ' s planning of cure).
Day +30: The above procedure is repeated. Day +90: In case of response, a third
administration following the above procedures will be repeated
Evaluation of response Response is assessed at 30, 90 and 180 days after TACE, monitoring
tumor dimension using Chest-abdomen CAT scan with and without contrast medium, and cancer
markers (CEA, Carbohydrate Antigen (CA) 19.9) Tumor response is performed according to the
Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Assessment of quality of life Assessment of quality of life with alliative Performance Scale
PPSv2 is performed during the baseline visit and 30, 60 and 180 days after treatment.
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