N/A N=20 Treatment

Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Liver Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00293397 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Jul 2018

Primary outcome: Primary: Safety — 16; 3 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Drug-eluting beads loaded with doxorubicin hydrochloride (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety	8; 1	—
PRIMARY Safety	8; 1	—
PRIMARY Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria	6; 6; 8; 0; 19	—
PRIMARY Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)	1; 7; 11; 1; 19	—
PRIMARY Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)	1; 7; 11; 1; 19	—
PRIMARY Efficacy - Overall Survival	11	—
PRIMARY Efficacy - Overall Survival	11	—

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification
No advanced disease, as defined by any of the following:
Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:
Vascular invasion, including segmental portal obstruction
Extrahepatic spread
Cancer-related symptoms (PST of 1-2)
BCLC class D disease, as defined by the following:
Okuda stage III disease
World Health Organization (WHO) performance status 3 or 4
Diffuse HCC, defined as massive ill-defined tumor involvement
Child-Pugh Class C
Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
No significant liver decompensation
Preserved liver function (Child-Pugh class A-B)
No ascites (trace ascites allowed)
No other active primary tumor
Arteries supplying the lesion must be large enough to accept GelSpheres™ beads

PATIENT CHARACTERISTICS:

Bilirubin ≤ 3 mg/dL
Albumin > 2.0 g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
No active gastrointestinal bleeding
No encephalopathy
No contraindication to hepatic embolization procedures, as indicated by any of the following:
Porto-systemic shunt
Hepatofugal blood flow
Platelet count 5 mg/dL
White blood cell (WBC) < 1,500/mm^3
Ejection fraction < 50% by isotopic ventriculography or echocardiography
Not pregnant
No known allergy to contrast media
No intolerance to occlusion procedures
No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:
Active or risk of hemorrhage
Patent extra-to-intracranial anastomoses or shunts
End arteries leading directly to the cranial nerves
Feeding arteries smaller than distal branches from which they emerge
Collateral vessel pathways that would potentially endanger normal territories during embolization

PRIOR CONCURRENT THERAPY:

No prior anticancer therapy for HCC

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00293397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.