Adults 18 to 75, any sex, with Localized Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)Primary· At 6 months
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of
6-month ORR (EASL criteria)
Group
Value
95% CI
Single -Arm
75
6-month ORR (mRECIST criteria)
Group
Value
95% CI
Single -Arm
73
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 MonthsSecondary· At 12 months
Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as "time to treatment failure") will be measured by a few data items list below:
* The date of the disease progression in the Overall Response form
* The date of lost-to-follow due to:
* Adverse events
* Progressiv
EASL
Group
Value
95% CI
Single -Arm
10
mRECIST
Group
Value
95% CI
Single -Arm
8
Number of Participants With Objective Tumor Response at 30-daySecondary· At 1month
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of
EASL Response
Group
Value
95% CI
Single -Arm
86
mRECIST Response
Group
Value
95% CI
Single -Arm
86
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 MonthsSecondary· from first TACE to 12 months
Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC.
The data items to be captured will include:
* The date of the disease progression in the Overall Response form
* The very last date by scanning all available dates in the database
* The desired cut-off days The proportion of any time point will be determined by the Kaplan-Meier estimates.
EASL
Group
Value
95% CI
Single -Arm
10
mRECIST
Group
Value
95% CI
Single -Arm
8
Kaplan-Meier Analyses the Percent of Participants for Overall SurvivalSecondary· from first TACE to 12 months
Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored.
There are three critical data items to be captured:
* Death date
* The very last date in the database (e.g. follow-up visit date and/or site reported AE date)
* The desired cut-off days (e.g. 6-month OS at 182 days, 12-month OS at 365 days) In addition to the Kaplan-
Group
Value
95% CI
Single -Arm
100
Number of Adverse Events Relate to Study Device in 12 Months Post ProcedureSecondary· in 12 months
Number and documents of adverse events relate to study device in 12 months post procedure
SAEs of related with TANDEM Microspheres
Group
Value
95% CI
Single -Arm
17
Non-serious AEs of related with TANDEM Microspheresrate
Group
Value
95% CI
Single -Arm
301
Number of Participants With Objective Tumor Response at 3 MonthsSecondary· At 3 months
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of
EASL Response
Group
Value
95% CI
Single -Arm
84
mRECIST Response
Group
Value
95% CI
Single -Arm
85
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic SpreadSecondary· At 12 month
Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment.
The data items to be considered will include:
* The date of the extrahepatic spread in the Overall Response form
* The very last date by scanning all available dates in the database
* The desired cut-off days
Group
Value
95% CI
Single -Arm
20
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Single -Arm
Serious: 13/108 (12%)
Deaths: 7/108
Serious adverse events (12 terms)
Reaction
System
Single -Arm
Liver abscess
Hepatobiliary disorders
—
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Hepatic cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Duodenal ulcer haemorrhage
Gastrointestinal disorders
—
Sepsis
Infections and infestations
—
Jaundice hepatocellular
Hepatobiliary disorders
—
Headache
Nervous system disorders
—
Pyrexia
General disorders
—
Anaemia
Blood and lymphatic system disorders
—
Post embolisation syndrome
Injury, poisoning and procedural complications
—
Other adverse events (7 terms — click to expand)
Reaction
System
Single -Arm
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
—
Gastrointestinal disorders
Gastrointestinal disorders
—
Investigations
Blood and lymphatic system disorders
—
General disorders and administration site conditions
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Varian Medical Systems
Last refreshed: 1 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03113955.