Trial Outcomes & Findings for HepaSphere™ Microspheres Prospective Registry (NCT NCT04866290)

Last Updated: 2023-04-03

Results Overview

Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

24 months

Results posted on

2023-04-03

Participant Flow

Study enrollment began in September 2016 and ended in May 2019.

Participant milestones

Participant milestones
Measure	Patients With Metastatic Colorectal Cancer to the Liver This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Enrolled and Completion of TACE Cycle 1 STARTED	105
Enrolled and Completion of TACE Cycle 1 COMPLETED	105
Enrolled and Completion of TACE Cycle 1 NOT COMPLETED	0
Completion of TACE Cycle 2 STARTED	105
Completion of TACE Cycle 2 COMPLETED	58
Completion of TACE Cycle 2 NOT COMPLETED	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=105 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Age, Continuous	66 years STANDARD_DEVIATION 10.2 • n=105 Participants
Sex: Female, Male Female	22 Participants n=105 Participants
Sex: Female, Male Male	83 Participants n=105 Participants
Region of Enrollment Greece	100 Participants n=105 Participants
Region of Enrollment France	5 Participants n=105 Participants
Baseline Disease Status: Tumor Location Unilobar Liver Disease/Tumor Location	65 Participants n=105 Participants
Baseline Disease Status: Tumor Location Bilobar Liver Disease/ Tumor Location	40 Participants n=105 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All enrolled subjects received one or more TACE Cycles and therefore were included in the calculation of the primary endpoint, Median Overall Survival.

Outcome measures

Outcome measures
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=105 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Overall Survival	19 months Interval 14.0 to 23.0

SECONDARY outcome

Timeframe: 24 months

Population: Only subjects with complete imaging could be analyzed. Eighty three of the subjects had imaging and were evaluated using mRECIST criteria to calculate the objective response rate (ORR).

Determined by the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) when all subjects enrolled have been followed for survival for 2 years (from date of 1st TACE), are considered lost to follow up, or have died, whichever comes first. Per mRECIST (target lesions assessed by MRI): Complete Response (CR), at least \>=30% decrease in the sum of diameters of all viable target lesions, Partial Response (PR), at least a \>=30% decrease in the sum of diameters of all viable target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Overall Response (OR) = CR + PR. ORR is calculated as= (no. of patients with CR + the no. of patients with PR) / N. (N= No of participants analyzed)

Outcome measures

Outcome measures
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=83 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Objective Response Rate (ORR) Complete Response (CR)	5 Participants
Objective Response Rate (ORR) Partial Response (PR)	30 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Only subjects with complete imaging could be analyzed. Eighty three of the subjects had imaging and were evaluated using mRECIST criteria.

Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI: Complete Response (CR), at least \> =30% decrease in the sum of diameters of all viable ( enhancement in the arterial phase) target lesions, Partial Response (PR), at least a \>=30% decrease in the sum of diameters of all viable (enhancement in the arterial phase) target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Best Tumor Response (BTR) was assessed during the period of time between TACE Cycle 1 and the last post-TACE MRI or CT. BTR will be presented as the number of subjects within each response category and percentage of evaluated subjects.

Outcome measures

Outcome measures
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=83 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Best Tumor Response Complete Response (CR)	5 Participants
Best Tumor Response Partial Response (PR)	30 Participants
Best Tumor Response Stable Disease (SD)	25 Participants
Best Tumor Response Progressive Disease (PD)	23 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Only 17 subjects had data available to calculate progression free survival (definition: a lack of tumor progression in the liver as determined by mRECIST criteria).

Median liver progression-free survival will be calculated as the time (in months) between the first TACE procedure to the date on which progression of the subject's liver metastases was documented or the date of death (from any cause). Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI, Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started.

Outcome measures

Outcome measures
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=17 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Liver Progression-free Survival	4.0 months Interval 3.0 to NA Explanation: The confidence interval cannot be calculated for the upper bounds of median survival because less than 50% of events (e.g. alive, death) have occurred from the low sample of 17 subjects. The upper limit of the survival curve has not reached 50% and thus, there is no estimate for the upper confidence limit on the median.

SECONDARY outcome

Timeframe: 24 months

Population: A total of 87 subjects had disease progression after one or more study TACE procedures, 66 with hepatic progression and 21 with extrahepatic progression.

Time to Progression (TTP) was defined as the length of time between TACE Cycle 1 and disease progression (as determined by MRI or CT imaging) of both hepatic and extrahepatic disease. The date of the first study TACE was time zero.

Outcome measures

Outcome measures
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=87 Participants This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Time to Progression Hepatic Liver Disease	7.0 Months Interval 6.0 to 9.0
Time to Progression Extra Hepatic Disease	6.0 Months Interval 3.0 to 9.0

Adverse Events

Patients With Metastatic Colorectal Cancer to the Liver

Serious events: 1 serious events

Other events: 97 other events

Deaths: 79 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=105 participants at risk This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor rupture	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.

Other adverse events

Other adverse events
Measure	Patients With Metastatic Colorectal Cancer to the Liver n=105 participants at risk This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent.
Gastrointestinal disorders Abdominal pain upper	84.8% 89/105 • Number of events 180 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Gastrointestinal disorders Nausea	26.7% 28/105 • Number of events 31 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Gastrointestinal disorders Vomiting	18.1% 19/105 • Number of events 20 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
General disorders Fatigue	16.2% 17/105 • Number of events 18 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
General disorders Pyrexia	3.8% 4/105 • Number of events 5 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Infections and infestations Abscess	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Infections and infestations Liver abscess	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Injury, poisoning and procedural complications Overdose	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Investigations Blood bilirubin increased	11.4% 12/105 • Number of events 16 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Investigations Hepatic enzyme increased	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Investigations Transaminases increased	9.5% 10/105 • Number of events 12 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
Investigations White blood cell count increased	0.95% 1/105 • Number of events 1 • Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days. Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.

Additional Information

Vicky Brunk RN, Vice President, Medical Affairs, Merit Medical

Merit Medical Systems, Inc.

Phone: +1 (717) 873-3309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60