Trial Outcomes & Findings for Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver (NCT NCT00003907)

Last Updated: 2023-07-05

Results Overview

Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) \>=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)\>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)\>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Assessed every 3 months for 2 years, then every 6 months for 3 year.

Results posted on

2023-07-05

Participant Flow

Participants were recruited from ECOG membership institution between August 6, 1999 and September 15, 2006. The first patient was accrued on December 15, 1999.

Participant milestones

Participant milestones
Measure	Hepatocellular Carcinoma Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Overall Study STARTED	19	31
Overall Study Eligible	18	29
Overall Study Received Protocol Therapy (Treated)	18	31
Overall Study Eligible and Treated	17	29
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	13	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Hepatocellular Carcinoma Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Overall Study Adverse Event	2	11
Overall Study Death	2	0
Overall Study Withdrawal by Subject	1	3
Overall Study Progressive disease	4	4
Overall Study Complicating disease	1	0
Overall Study Other	1	3
Overall Study ineligible or not treated	2	2

Baseline Characteristics

Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatocellular Carcinoma n=17 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=29 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Total n=46 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	29 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 year.

Population: All eligible and treated patients

Outcome measures

Outcome measures
Measure	Hepatocellular Carcinoma n=17 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=29 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Time to Progression	2.3 Months Interval 1.1 to 24.0	7.2 Months Interval 4.4 to 17.3

SECONDARY outcome

Timeframe: Assessed every 6 weeks

Population: all eligible and treated patients

Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as \>= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.

Outcome measures

Outcome measures
Measure	Hepatocellular Carcinoma n=17 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=29 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Tumor Response	0 Proportion of participants Interval 0.0 to 0.16	0.17 Proportion of participants Interval 0.07 to 0.33

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 year.

Population: all eligible and treated patients

Overall survival was defined as time from registration to death from any causes.

Outcome measures

Outcome measures
Measure	Hepatocellular Carcinoma n=17 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=29 Participants Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Overall Survival	12.0 Months Interval 3.9 to 27.6	21.2 Months Interval 9.7 to 38.1

Adverse Events

Hepatocellular Carcinoma

Serious events: 18 serious events

Other events: 18 other events

Deaths: 0 deaths

Neuroendocrine Hepatic Metastases

Serious events: 30 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Hepatocellular Carcinoma n=18 participants at risk Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=31 participants at risk Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Blood and lymphatic system disorders Anemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	12.9% 4/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia (Neutrophils, decreased)	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia (Platelets, decreased)	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Blood and lymphatic system disorders Transfusion: pRBCs	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Cardiac disorders Supraventricular arrhythmias	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Vascular disorders Acute vascular leak syndrome	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Cardiac disorders Cardiac-ischemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	12.9% 4/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Vascular disorders Hypertension	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	9.7% 3/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Vascular disorders Hypotension	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Injury, poisoning and procedural complications Operative injury of vein/artery	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Fever	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Weight gain	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations PT	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Pruritus	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Colitis	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Ileus	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	22.6% 7/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Vascular disorders Hemorrhage with grade 3 or 4 platelets	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders GI-other	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Melena/GI bleeding	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Alkaline phosphatase	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	9.7% 3/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Bilirubin	22.2% 4/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Hepatobiliary disorders Hepatic enlargement	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 3/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	12.9% 4/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Hepatobiliary disorders Liver dysfunction/failure	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations SGOT	100.0% 18/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	83.9% 26/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations SGPT	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	19.4% 6/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Hepatobiliary disorders Hepatic-other	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	9.7% 3/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection w/o neutropenia	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Hypercholesterolemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Nervous system disorders Arachnoiditis	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Psychiatric disorders Confusion	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Nervous system disorders Dizziness/lightheadedness	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection-other	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	16.1% 5/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Hepatobiliary disorders Hepatic pain	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Creatinine	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Renal and urinary disorders Renal failure	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Tumor lysis syndrome	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	0.00% 0/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.

Measure	Hepatocellular Carcinoma n=18 participants at risk Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Neuroendocrine Hepatic Metastases n=31 participants at risk Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Blood and lymphatic system disorders Anemia	88.9% 16/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	67.7% 21/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Leukopenia (Leukocytes, decreased)	16.7% 3/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	22.6% 7/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia (Neutrophils, decreased)	0.00% 0/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	19.4% 6/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia (Platelets, decreased)	61.1% 11/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	45.2% 14/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Edema	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	50.0% 9/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	51.6% 16/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Fever	38.9% 7/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	29.0% 9/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Rigors/chills	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	9.7% 3/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Weight loss	16.7% 3/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	35.5% 11/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations PT	55.6% 10/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	29.0% 9/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Alopecia	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	9.7% 3/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	22.2% 4/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	41.9% 13/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Ascites	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	12.9% 4/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	6.5% 2/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	55.6% 10/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	67.7% 21/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	38.9% 7/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	67.7% 21/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	25.8% 8/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Alkaline phosphatase	83.3% 15/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	77.4% 24/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Bilirubin	38.9% 7/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	32.3% 10/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 12/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	54.8% 17/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	41.9% 13/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Hepatobiliary disorders Hepatic pain	11.1% 2/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
General disorders Pain-other	16.7% 3/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Investigations Creatinine	16.7% 3/18 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.	3.2% 1/31 • Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.