Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim

Study Overview
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Brief Summary
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Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to conventional therapy inoperable liver cancers by in situ introduction of ImDendrim. Trial Design: An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or metastatic liver without standard therapeutic options for treatment including chemotherapy or surgery.

Detailed Description
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Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to conventional therapy inoperable liver cancers by in situ introduction of ImDendrim [188Re] rhenium complex coupled to a imidazolic ligand and associated with a dendrimer. Trial Design: Type of the clinical Trial: An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or metastatic liver without standard therapeutic options for treatment including chemotherapy or surgery. Duration and method The trial will be comprised of 12 weeks of continued observation following in situ injection of ImDendrim into a subject suffering non-responding to conventional therapy inoperable liver cancers.

Official Title
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Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim [188Re]Rhenium Complex Coupled to an Imidazolic Ligand and Associated With a Dendrimer

Conditions
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Efficacy and Safety

Intervention / Treatment
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* Device: IMDENDRIM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have given written informed consent. Female or male aged 18 years and over. Confirmed histological diagnosis of primary hepatocellular cancer or metastatic liver without standard therapeutic options for treatment including chemotherapy or surgery. Not more than 5 measurable lesions at least 20 mm in the longest diameter by spiral Computed Tomography (CT) scan. Patients with hepatic tumor extended without discontinuity to regional structures are accepted (including vascular axis, lymphatic nodes and others organs namely pancreas, billiary vesicle and peritonea). Life expectancy of 12 weeks or longer. Patient with no contraindication to local anaesthesia. Karnofsky index ≥ 70% Negative pregnancy test for women of childbearing potential. - Women should be under effective contraceptive method during at least trial period Exclusion Criteria: Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy. Any metastasis no located in liver (liver tumor extended without discontinuity to other regional structures are accepted, see inclusion criteria). Pregnancy or breast feeding (women of child-bearing potential). Comorbidity with a grave prognosis (estimated survival <3 months) and/or worse then the basic disease for which the patients will be included in the study. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. Patients who are declared incompetent. Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy. Active hepatitis (B and/or C). Allergy for I.V. contrast or anesthesic agents used. Scan or MRI contra-indications: severe claustrophobia, metal shrapnel, implanted pacemaker and/or neurostimulators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 10 patients with liver tumor non operable, with resistance to other classical chemotherapy, injected a single dose of IMDENDRIM 10 mCi per 1 cm²
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMDENDRIM<br> | Device: IMDENDRIM<br>* In situ and intra tumoral injection of non removal nanodevice IMDENDRIM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of tumor | evaluation criteria for solid tumors RECIST | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival PFS | PFS-end-point was defined as either Imaging progression or death of any cause | 12 weeks | 
| HPFS | Hepatic free survival | 12 weeks |