Clinical trial NCT03255343: Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim
Official title: 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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy and Safety
Lead sponsor: French Association for the Advancement Medical Research
Sponsor class: OTHER
Collaborators: name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2017-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients must have given written informed consent.
2. Female or male aged 18 years and over.
3. 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).
4. Life expectancy of 12 weeks or longer.
5. Patient with no contraindication to local anaesthesia.
6. Karnofsky index ≥ 70%
7. Negative pregnancy test for women of childbearing potential. -
8. Women should be under effective contraceptive method during at least trial period

Exclusion Criteria:

1. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
2. Any metastasis no located in liver (liver tumor extended without discontinuity to other regional structures are accepted, see inclusion criteria).
3. Pregnancy or breast feeding (women of child-bearing potential).
4. 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.
5. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
6. Patients who are declared incompetent.
7. 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.
8. Active hepatitis (B and/or C).
9. Allergy for I.V. contrast or anesthesic agents used.
10. Scan or MRI contra-indications: severe claustrophobia, metal shrapnel, implanted pacemaker and/or neurostimulators.

Primary outcomes:
measure: size of tumor
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression free survival PFS
timeFrame: 12 weeks
measure: HPFS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji University Eastern Hospital
Study officials:
affiliation: AFPREMED
name: Bertrand NASSAR, MD, PhD
role: STUDY_DIRECTOR
References: