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

Primary Purpose

Efficacy and Safety

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IMDENDRIM
Sponsored by
French Association for the Advancement Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tongji University Eastern HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMDENDRIM

Arm Description

Outcomes

Primary Outcome Measures

size of tumor
evaluation criteria for solid tumors RECIST

Secondary Outcome Measures

Progression free survival PFS
PFS-end-point was defined as either Imaging progression or death of any cause
HPFS
Hepatic free survival

Full Information

First Posted
August 8, 2017
Last Updated
August 18, 2017
Sponsor
French Association for the Advancement Medical Research
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03255343
Brief Title
Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim
Acronym
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Association for the Advancement Medical Research
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy and Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMDENDRIM
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IMDENDRIM
Intervention Description
In situ and intra tumoral injection of non removal nanodevice IMDENDRIM
Primary Outcome Measure Information:
Title
size of tumor
Description
evaluation criteria for solid tumors RECIST
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Progression free survival PFS
Description
PFS-end-point was defined as either Imaging progression or death of any cause
Time Frame
12 weeks
Title
HPFS
Description
Hepatic free survival
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAFID BELHADJ-TAHAR, MD, PhD
Phone
00336467722224
Email
belhadj-tahar@afpremed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nouredine SADEG, PhD
Phone
0033679343657
Ext
0033679343657
Email
nouredinesadeg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand NASSAR, MD, PhD
Organizational Affiliation
AFPREMED
Official's Role
Study Director
Facility Information:
Facility Name
Tongji University Eastern Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghua YANG, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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