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Status unknownNCT03255343ImDendrimUpdated Aug 21, 2017

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

An interventional study of IMDENDRIM in Efficacy and Safety, sponsored by French Association for the Advancement Medical Research. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-21.

Sponsored by French Association for the Advancement Medical Research · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Efficacy and Safety

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    IMDENDRIM

    Device: IMDENDRIM

Interventions

  • DeviceIMDENDRIM

    In situ and intra tumoral injection of non removal nanodevice IMDENDRIM

05

What researchers measure

Primary outcomes

  1. size of tumor

    evaluation criteria for solid tumors RECIST

    Time frame: 12 weeks

Secondary outcomes

  1. Progression free survival PFS

    PFS-end-point was defined as either Imaging progression or death of any cause

    Time frame: 12 weeks

  2. HPFS

    Hepatic free survival

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
  • Tongji University Eastern Hospital
    Shanghai, China
    • Guanghua YANG, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03255343
Lead sponsor
French Association for the Advancement Medical Research
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Mar 13, 2017
Primary completion
Oct 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Aug 21, 2017

Study contacts

HAFID BELHADJ-TAHAR, MD, PhD
Contact
belhadj-tahar@afpremed.org
00336467722224
Nouredine SADEG, PhD
Contact
nouredinesadeg@gmail.com
0033679343657 ext. 0033679343657
Bertrand NASSAR, MD, PhD
study director · AFPREMED

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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