Phase 2
N=74
Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors
Neuroendocrine Tumors · Hepatic Metastases · Metastases
Bottom Line
View on ClinicalTrials.gov: NCT01678664 ↗Enrolled (actual)
74
Serious AEs
47.3%
Results posted
Sep 2024
Primary outcome: Primary: Rate of Hepatic Progression Free Survival at 24 Months — 47; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug); embolization (Device); Doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Federation Francophone de Cancerologie Digestive
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Hepatic Progression Free Survival at 24 Months |
47; 20 | — |
| SECONDARY Progression-free Survival (Hepatic or Not) |
16.9 | — |
| SECONDARY Overall Survival |
51.0 | — |
Summary
Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.
* H0 a 24 months progression free survival rate less than 35% is unacceptable
* H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%
Eligibility Criteria
Inclusion Criteria
- Well differentiated (grade 1 and 2 according to WHO classification 2010 appendix 2), histologically-proven endocrine tumor of the gastrointestinal tract (TENpath review mandatory),
- Measurable liver metastasis (or metastases) as defined in RECIST v1.1 that are unresectable and inaccessible to radiofrequency ablation-type local treatment
- Hepatic arterial embolization or chemoembolization indicated for tumor size reduction, confirmed in an multidisciplinary team (MDT) meeting, due to the progressive nature of the liver metastases (morphological progression during the past 12 months as defined in RECIST v1.1)
- Age ≥ 18 years
- WHO performance status ≤ 2
- No contraindications to embolization or chemoembolization or everolimus
- Satisfactory laboratory assessments: Neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, Hb > 10 g/dL, serum bilirubin ≤ 1.5 x the upper limit of normal (ULN), INR 8%
- Chronic corticosteroid or immunosuppressant therapy
- Hypersensitivity to everolimus, other rapamycin derivatives, or one of the excipients
- Major surgery, open biopsy, or significant traumatic lesion during the 28 days prior to starting the investigational treatment Incompletely healed wound or foreseeable need for major surgery during the study
- Contraindication to vascular occlusion procedures: Portal thrombosis, biliodigestive anastomosis
- Malignancy during the past 5 years, with the exception of curatively treated basal cell skin carcinoma or in situ cervical cancer
- Foreseeable non-compliance
- Medical, geographic, sociological, psychological, or legal situation that would preclude the patient from completing the study or signing an informed consent form
- Pregnant or breast-feeding women
- Men or women of child-bearing potential not using effective contraception
- Concurrent participation in another investigational study that could affect the primary endpoint of this study
Data sourced from ClinicalTrials.gov (NCT01678664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.