Trial Outcomes & Findings for Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II (NCT NCT02185768)
NCT ID: NCT02185768
Last Updated: 2025-07-04
Results Overview
The main judgement criterion is the rate of patients in objective response (complete or partial response) at 6 months according to the mRECIST criteria and based on the central review. Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0) for target lesions was assessed by MRI Complete Response (CR) was defined as : Disappearance of all target lesions and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response was defind as the number of patients with a CR or a PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
up to 6 months
Results posted on
2025-07-04
Participant Flow
Forty-six patients were included by 7 centers between January 2015 and June 2016.
Participant milestones
| Measure |
DC-BEADS + Idarubicin
Two vials of 100-300 μm of drug-eluting beads (DC Bead) were loaded with 10 mg of idarubicin in aseptic conditions at the hospital pharmacies prior to TACE. Rapidly, 10 mg of idarubicin were reconstituted with 5 mL of sterile water for injection. As much saline as possible was removed from the two vials to add 5 mg (ie, 2.5 mL) of idarubicin. After a loading time of 60 minutes, the solution containing idarubicin-loaded beads was transferred to a 30-mL syringe. Just before injection, the interventional radiologists added 5 mL per milliliter of beads of a nonionic contrast medium to the syringe containing idarubicin-eluting beads. It was recommended to use 2.4-F to 2.8-F microcatheters for the catherization of tumor feeders, to perform cone-beam CT as soon as deemed necessary, and to inject the beads slowly (ideally 1 mL/min) through a 1-mL syringe until either complete delivery of the beads or reduced flow of the feeding artery with the conventional method of two to five heartbeats to clear the contrast column from the microcatheter tip.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
DC-BEADS + Idarubicin
Two vials of 100-300 μm of drug-eluting beads (DC Bead) were loaded with 10 mg of idarubicin in aseptic conditions at the hospital pharmacies prior to TACE. Rapidly, 10 mg of idarubicin were reconstituted with 5 mL of sterile water for injection. As much saline as possible was removed from the two vials to add 5 mg (ie, 2.5 mL) of idarubicin. After a loading time of 60 minutes, the solution containing idarubicin-loaded beads was transferred to a 30-mL syringe. Just before injection, the interventional radiologists added 5 mL per milliliter of beads of a nonionic contrast medium to the syringe containing idarubicin-eluting beads. It was recommended to use 2.4-F to 2.8-F microcatheters for the catherization of tumor feeders, to perform cone-beam CT as soon as deemed necessary, and to inject the beads slowly (ideally 1 mL/min) through a 1-mL syringe until either complete delivery of the beads or reduced flow of the feeding artery with the conventional method of two to five heartbeats to clear the contrast column from the microcatheter tip.
|
|---|---|
|
Overall Study
Patients were not treated
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DC-BEADS + Idarubicin
n=46 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Age, Continuous
|
71.25 years
STANDARD_DEVIATION 10.21 • n=46 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=46 Participants
|
|
Region of Enrollment
France
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: The modified intention-to-treat (mITT) population was defined as all evaluable patients included in the study regardless of eligibility criteria. A patient was considered evaluable if the patient had at least one chemoembolization and one post-treatment evaluation.
The main judgement criterion is the rate of patients in objective response (complete or partial response) at 6 months according to the mRECIST criteria and based on the central review. Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0) for target lesions was assessed by MRI Complete Response (CR) was defined as : Disappearance of all target lesions and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response was defind as the number of patients with a CR or a PR.
Outcome measures
| Measure |
DC-BEADS + Idarubicin
n=44 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed According Central Review
Objective response
|
22 Participants
|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed According Central Review
No objective response
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsThe rate of patients in objective response (complete or partial response) at 6 months according to the mRECIST criteria, and assessed according to the investigator. Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0) for target lesions wasassessed by MRI Complete Response (CR) was defined as : Disappearance of all target lesions and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response was defind as the number of patients with a CR or a PR.
Outcome measures
| Measure |
DC-BEADS + Idarubicin
n=44 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed by the Investigator
Complete response
|
12 Participants
|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed by the Investigator
Partial response
|
8 Participants
|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed by the Investigator
Stability
|
0 Participants
|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed by the Investigator
Progression
|
23 Participants
|
|
Number of Participants With Complete Response or Partial Response (Objective Response), as Assessed by the Investigator
Non evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 6 months after last chemoembolisationThe best response according to the mRECIST criteria. Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0) for target lesions was assessed regarding all MRI done for patient during its treatment period.
Outcome measures
| Measure |
DC-BEADS + Idarubicin
n=44 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Best Response According to mRECIST v1.0 in MRI
Complete response
|
17 Participants
|
|
Best Response According to mRECIST v1.0 in MRI
Partial response
|
13 Participants
|
|
Best Response According to mRECIST v1.0 in MRI
Stability
|
8 Participants
|
|
Best Response According to mRECIST v1.0 in MRI
Progression
|
5 Participants
|
|
Best Response According to mRECIST v1.0 in MRI
Non evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Analysis was done on the ITT population
It was defined by the time interval between the inclusion date and the date of the 1st progression according to the mRECIST criteria (assessed in central review) or death (regardless of the cause). Alive patients without progression were censored at date of the last news.
Outcome measures
| Measure |
DC-BEADS + Idarubicin
n=46 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Progression-Free Survival
|
6.57 months
Interval 5.85 to 11.99
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Analysis was done on the ITT population
It was defined by the time interval between the inclusion date and date of death (regardless of the cause) or date of the last news for alive patients.
Outcome measures
| Measure |
DC-BEADS + Idarubicin
n=46 Participants
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Overall Survival
|
18.55 months
Interval 11.73 to 29.08
|
Adverse Events
DC-BEADS + Idarubicin
Serious events: 15 serious events
Other events: 43 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
DC-BEADS + Idarubicin
n=44 participants at risk；n=46 participants at risk
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/46 • Number of events 1 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Cardiac disorders
Acute coronary syndrome
|
2.2%
1/46 • Number of events 1 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Ascite
|
2.2%
1/46 • Number of events 1 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Upper GI haemorrhage
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Varices Oesophageal
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
General disorders
Asthenia
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Hepatobiliary disorders
Biloma
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Hepatobiliary disorders
Cholangitis
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Hepatobiliary disorders
Jaundice
|
4.3%
2/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Infections and infestations
Bacteraemia
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Infections and infestations
Bacterial infection
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Infections and infestations
Liver abscess
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Infections and infestations
Peritonitis
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Infections and infestations
Pyelonephritis
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Injury, poisoning and procedural complications
Post-embolisation syndrome
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
C-reactive protein increased
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Psychiatric disorders
Delusion
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Vascular disorders
Malignant hypertension
|
2.2%
1/46 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
Other adverse events
| Measure |
DC-BEADS + Idarubicin
n=44 participants at risk；n=46 participants at risk
Chemoembolization with DC BEAD loaded with idarubicin
idarubicin
Dc- Beads 300-500µm
|
|---|---|
|
Nervous system disorders
Cephalgia
|
6.8%
3/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
6.8%
3/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Blood and lymphatic system disorders
Anemias
|
36.4%
16/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Vascular disorders
Hypertension
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
General disorders
Pain
|
34.1%
15/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
70.5%
31/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
33/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Total Bilirubin increased
|
63.6%
28/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Creatinine increased
|
11.4%
5/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Gammaglutamyltransferase increased
|
61.4%
27/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
White blood cell count decreased
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Lipase increased
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Neutropenia
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Lymphocytes decreased
|
27.3%
12/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Phosphatases alcalines increased
|
36.4%
16/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Investigations
Platelets decreased
|
52.3%
23/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
52.3%
23/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
4/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
47.7%
21/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.4%
5/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hypokaliemia
|
6.8%
3/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.8%
3/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
34.1%
15/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.8%
3/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
General disorders
Asthenia
|
18.2%
8/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
|
General disorders
Fever
|
40.9%
18/44 • Up to the end of treatment. The mean treatment duration was 6 months. After the definitive stop of the protocol, patients were only followed-up for the overall survival up to 3 years
|
Additional Information
Karine Le Malicot
Fédération Francophone de Cancérologie Digestive
Phone: +33 3 80 39 34 79
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place