Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

sorafenib: given 400 mg twice per day for as long as it is beneficial

sorafenib

LC Beads loaded with doxorubicin

Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period

LC Bead-TACE

This study will combine two therapies to treat patients with unresectable hepatocellular carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the study is to establish the safety and the effectiveness of the combination therapy. The investigators hypothesize that the combination of the two therapies will not result in greater toxicities to patients than that expected for either therapy given alone.

Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma

Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma

Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve.

Percentage of study patients surviving after three years from initial treatment analyzed with Kaplan-Meier curve.

Median overall survival stratified by Barcelona Clinic Liver Cancer (BCLC) staging as assessed by Kaplan-Meier estimator. Patients are grouped to stages A (early), B (intermediate), and C (advanced) according to stage of disease.

Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.

Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more.

Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6 months post the initiation of treatment. 33 out of the original 50 patients were evaluable at this time point, with 17 out of the 50 exiting prior to 6 months or were not assessable by RECIST criteria.

Complete response (CR): Disappearance of all lesions targeted with therapy Partial Response (PR): at least 30% decrease in sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): at least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD

Efficacy as assessed by radiographic tumor response using the EASL criteria at baseline and at 6 months post the initiation of treatment.

Complete response (CR): 100% tumor necrosis Partial Response (PR): more than 50% tumor necrosis Progressive Disease (PD): increase in tumor enhancement by more than 25% Stable Disease (SD): Cases that do not qualify for one of the above criteria

Time to progression (TTP) - defined as the time from initiation of therapy to disease progression (radiological). Median TTP calculated for all subjects and stratified by Barcelona Clinic Liver Cancer (BCLC) staging.

46 patients out of 50 were reviewed for this outcome. 3 patients were excluded because they underwent liver transplantation and 1 patient was excluded for hepatic resection.

Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.

All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib.

Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.

Bayer

Biocompatibles UK Ltd

Yale University

single arm

sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial

LC Bead-TACE: LC Beads loaded with doxorubicin

Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period

Sorafenib and Drug Eluting Beads

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jean-Francois Geschwind, MD

Anemia

Lymphopenia

Thrombocytopenia

Arrhythmia

Chest pain

Dissection

Embolus or coagulopathy

Hypertension

Lower extremity edema

Fatigue

Fever

Hand-foot skin reaction

Mucositis

Rash

Skin pain

Ascites

Anorexia

Diarrhea

Nausea or vomiting

Epistaxis or hemoptysis

Hematochezia

Hematoma

Tumor rupture

Elevated ALT level

Elevated AST level

Elevated AP level

Elevated amylase level

Elevated lipase level

Elevated INR level

Hyperbilirubinemia

Hypoalbuminemia

Infection

Dizziness

Headache

Encephalopathy

Nonspecific abdominal pain

Musculoskeletal pain

Right upper quadrant pain

Pain - other

Acute renal failure

Death (disease progression)

Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.

Pancytopenia

Cholangitis

Liver abscess

39 patients were reviewed for toxicities for Cycle 2-5+. 11 patients out of the original 50 exited the study prior to Cycle 2.

Complete Response

Partial Response or Stable Disease

Progressive Disease

Disease control rate (CR + PR + SD)

33 out of the original 50 patients were evaluable for this outcome, with 17 out of the original 50 exiting prior to 6 months or were not assessable by RECIST criteria.

Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate

Partial Response

Stable Disease

32 out of the 50 patients had imaging assessable by EASL criteria at 6 months - 18 out of the original 50 had exited prior to this time point or did not have applicable imaging.

Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate

Median TTP

Median TTP for BCLC stage A

Median TTP for BCLC stage B

Median TTP for BCLC stage C

Median TTP stratified by BCLC staging; 3 patients had BCLC stage A disease, 14 with stage B, and 29 with stage C.

Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE

Efficacy - Overall Survival (OS) After Combination Treatment With Sorafenib and TACE

Median liver tumor burden >10%

Median tumor size > 10cm

ECOG performance status

BCLC stage

Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE

All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib.

Estimated Percentage of Participants Surviving After One Year

Estimated Percentage of Participants Surviving After Three Year

BCLC A

BCLC B

BCLC C

50 total participants received sorafenib on trial. 3 were classified as BCLC A, 16 as BCLC B, and 31 as BCLC C.

Median Overall Survival OS Stratified by BCLC Criteria

Overall Study

Spots Global Cancer Trial Database for Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial