A Phase 2 interventional study of HIA DEBIRI + systemic FOLFOX in Colorectal Cancer With Non Resectable Hepatic Metastasis, sponsored by Federation Francophone de Cancerologie Digestive. Completed at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Federation Francophone de Cancerologie Digestive · Phase 2, Interventional, and Treatment
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.
Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.
Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.
The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's enrollment of 58 is below the median of 77 across 4,226 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Federation Francophone de Cancerologie Digestive is the lead sponsor of 63 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
Drug: HIA DEBIRI + systemic FOLFOX
Progression-free Survival Rate at 9 Months
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
Time frame: at 9 months after inclusion
Overall Survival
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.
Time frame: up to 4 years after patient's inclusion
Fifty eight patients were included in the study between May 2013 and December 2016.
| Milestone | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| Started | 58 |
| Completed | 57 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
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
| Participants | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| Patients alive without any progression | 30 |
| Patients with progression or death | 26 |
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.
| months | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| Overall Survival | 37.4 (25.7 to 45.8) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIA DEBIRI + Systemic FOLFOX | 31/57 (54.4%) | 27/57 (47.4%) | 57/57 (100%) |
| Event | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| DiarrhoeaGastrointestinal disorders | 4/57 |
| Pancreatitis acuteGastrointestinal disorders | 4/57 |
| PyrexiaGeneral disorders | 4/57 |
| PancreatitisGastrointestinal disorders | 3/57 |
| Clostridium difficile colitisInfections and infestations | 3/57 |
| EnteritisGastrointestinal disorders | 2/57 |
| Large intestinal obstructionGastrointestinal disorders | 2/57 |
| AstheniaGeneral disorders | 2/57 |
| Chest painGeneral disorders | 2/57 |
| CholecystitisHepatobiliary disorders | 2/57 |
| Event | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| AnemiaBlood and lymphatic system disorders | 56/57 |
| NeuropathyNervous system disorders | 49/57 |
| Alanine aminotransferase increasedInvestigations | 49/57 |
| Aspartate aminotransferase increasedInvestigations | 49/57 |
| Phosphatases alcalines increasedInvestigations | 47/57 |
| FatigueGeneral disorders | 43/57 |
| Platelets decreasedInvestigations | 36/57 |
| NeutropeniaInvestigations | 36/57 |
| NauseaGastrointestinal disorders | 32/57 |
| DiarrhoeaGastrointestinal disorders | 31/57 |
Baseline population is on ITT population meaning all patients included excepted the patient wrongly included (beacuase of pancreatic metastases and not colorectal metastases)
| Age, Continuous(years) | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| Mean | 63.14 ± 8.57 |
| Sex: Female, Male(Participants) | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| Female | 25 |
| Male | 32 |
| Race and Ethnicity Not Collected(Participants) | HIA DEBIRI + Systemic FOLFOX |
|---|
| Region of Enrollment(participants) | HIA DEBIRI + Systemic FOLFOX |
|---|---|
| France | 57 |
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Federation Francophone de Cancerologie Digestive