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Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

Phase 2
18 Years
Open (Enrolling)
Neuroendocrine Tumors, Hepatic Metastases, Metastases

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Trial Information

Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

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

- 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 < 1.3 (or < 3 for patients on anticoagulant therapy) ALT and AST ≤ 5 x ULN,
creatinine ≤ 1.5 x ULN, fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L and
triglycerides ≤ 2.5 x ULN (if either or both of these limits are exceeded, the
patient may only be included into the study after institution of appropriate
lipid-lowering therapy)

- Complete resolution of toxic effects of any prior treatments, or persistence at grade
1 at most (CTCAE version 4.0)

- Minimum time since previous treatment: 28 days

- Patient has been informed and has signed an informed consent form, after verification
of the eligibility criteria

- Patient covered by a French national health insurance scheme

Exclusion Criteria:

- Duodenopancreatic neuroendocrine tumor

- Poorly differentiated and/or grade 3 endocrine tumor,

- Embolization or chemoembolization indicated for symptomatic control only

- Prior hepatic TACE or embolization

- Prior treatment with an mTOR inhibitor (somatostatin analogs to control secretion are

- Symptomatic bone metastasis (or metastases)

- Any uncontrolled progressive disease: hepatic failure, renal failure, respiratory
failure, NYHA class III-IV congestive heart failure, unstable angina, myocardial
infarction, significant arrhythmia

- Interstitial lung disease

- Uncontrolled diabetes, defined by HbA1c > 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of hepatic progression free survival at 24 months

Outcome Description:

Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus (appendix 3). Progression-free survival rate (PFS) (based on the central assessment) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment.

Outcome Time Frame:

24 months after the last included patient

Safety Issue:


Principal Investigator

Emmanuel MITRY, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

FFCD 1104



Start Date:

October 2012

Completion Date:

April 2017

Related Keywords:

  • Neuroendocrine Tumors
  • Hepatic Metastases
  • Metastases
  • cancer
  • neuroendocrine tumors
  • gastrointestinal tract
  • metastases
  • liver
  • hepatic
  • Endocrine Gland Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neuroendocrine Tumors
  • Liver Neoplasms