Trial Outcomes & Findings for Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study (NCT NCT01839877)
NCT ID: NCT01839877
Last Updated: 2024-10-08
Results Overview
The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were: * Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator. * Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
at 9 months after inclusion
Results posted on
2024-10-08
Participant Flow
Fifty eight patients were included in the study between May 2013 and December 2016.
Participant milestones
| Measure |
HIA DEBIRI + Systemic FOLFOX
Patients received induction chemotherapy with FOLFOX: oxaliplatin 85 mg/m2 as a 2-h infusion at day 1, leucovorin 400 mg/m2 as a 120-min infusion at day 1 followed by 5FU 400 mg/m2 bolus at day 1 and 2400 mg/m2 46-h continuous 5FU infusion, 1 cycle every 2 weeks. Patients received treatment with DC Bead LUMI™ 100-300 loaded with irinotecan 50 mg/ml, 1 vial per lobe and per treatment (meaning 1 vial in case of unilobar administration, and 2 vials in case of bilobar administration). Each treatment session was performed 48-72 h after a chemotherapy cycle. Treatment administration was performed using a unilateral femoral approach.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HIA DEBIRI + Systemic FOLFOX
Patients received induction chemotherapy with FOLFOX: oxaliplatin 85 mg/m2 as a 2-h infusion at day 1, leucovorin 400 mg/m2 as a 120-min infusion at day 1 followed by 5FU 400 mg/m2 bolus at day 1 and 2400 mg/m2 46-h continuous 5FU infusion, 1 cycle every 2 weeks. Patients received treatment with DC Bead LUMI™ 100-300 loaded with irinotecan 50 mg/ml, 1 vial per lobe and per treatment (meaning 1 vial in case of unilobar administration, and 2 vials in case of bilobar administration). Each treatment session was performed 48-72 h after a chemotherapy cycle. Treatment administration was performed using a unilateral femoral approach.
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|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HIA DEBIRI + Systemic FOLFOX
n=57 Participants
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
HIA DEBIRI + systemic FOLFOX
|
|---|---|
|
Age, Continuous
|
63.14 years
STANDARD_DEVIATION 8.57 • n=57 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=57 Participants
|
|
Region of Enrollment
France
|
57 participants
n=57 Participants
|
PRIMARY outcome
Timeframe: at 9 months after inclusionPopulation: Primary endpoint was on mITT population meaning all the patients included in the study with at least one radiological assessments within the 9 months following the inclusion
The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were: * Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator. * Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun
Outcome measures
| Measure |
HIA DEBIRI + Systemic FOLFOX
n=56 Participants
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
HIA DEBIRI + systemic FOLFOX
|
|---|---|
|
Progression-free Survival Rate at 9 Months
Patients alive without any progression
|
30 Participants
|
|
Progression-free Survival Rate at 9 Months
Patients with progression or death
|
26 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after patient's inclusionPopulation: Endpoint was analyzed on the ITT population
It was defined as the time interval between the date of inclusion and the date of death (whatever the cause). Patients lost to follow-up or alive at the time of analysis were censored at the date of last news.
Outcome measures
| Measure |
HIA DEBIRI + Systemic FOLFOX
n=57 Participants
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
HIA DEBIRI + systemic FOLFOX
|
|---|---|
|
Overall Survival
|
37.4 months
Interval 25.7 to 45.8
|
Adverse Events
HIA DEBIRI + Systemic FOLFOX
Serious events: 27 serious events
Other events: 57 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
HIA DEBIRI + Systemic FOLFOX
n=57 participants at risk
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
HIA DEBIRI + systemic FOLFOX
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Enteritis
|
3.5%
2/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.5%
2/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Asthenia
|
3.5%
2/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Chest pain
|
3.5%
2/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
General physical health deterioration
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Injection site extravasation
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Malaise
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Pyrexia
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.5%
2/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Clostridium difficile colitis
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Escherichia bacteraemia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Peritonitis
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Sepsis
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Superinfection bacterial
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Superinfection
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Deshydratation
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor obstruction
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Vascular disorders
Venous thrombosis limb
|
1.8%
1/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
Other adverse events
| Measure |
HIA DEBIRI + Systemic FOLFOX
n=57 participants at risk
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
HIA DEBIRI + systemic FOLFOX
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.6%
14/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Renal and urinary disorders
Urinary retention
|
8.8%
5/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Immune system disorders
Allergic reaction
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Nervous system disorders
Cephalgia
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Nervous system disorders
Dysgeusia
|
8.8%
5/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Nervous system disorders
Neuropathy
|
86.0%
49/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
22.8%
13/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.4%
31/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.3%
15/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Mucositis
|
19.3%
11/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
56.1%
32/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
12.3%
7/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
29.8%
17/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Blood and lymphatic system disorders
Anemia
|
98.2%
56/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.0%
8/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
8.8%
5/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Hepatobiliary disorders
Hepatalgia
|
12.3%
7/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
6/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Vascular disorders
Thromboembolic event
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Vascular disorders
Hypertension
|
14.0%
8/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Infections and infestations
Urinary tractus infection
|
5.3%
3/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
86.0%
49/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
86.0%
49/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Total Bilirubin increased
|
19.3%
11/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Creatinine increased
|
17.5%
10/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Gammaglutamyltransferase increased
|
49.1%
28/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
White blood cell count decreased
|
21.1%
12/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Lymphocytes decreased
|
24.6%
14/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Phosphatases alcalines increased
|
82.5%
47/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Weight loss
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Platelets decreased
|
63.2%
36/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Investigations
Neutropenia
|
63.2%
36/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.6%
14/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.8%
9/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
7.0%
4/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.3%
15/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.3%
7/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hypokaliemia
|
24.6%
14/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
19/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Fatigue
|
75.4%
43/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
|
|
General disorders
Fever
|
43.9%
25/57 • Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 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