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

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"

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.

Study Overview

• Status: Unknown
• Conditions: Efficacy and Safety
• Intervention / Treatment: Device: IMDENDRIM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Tongji University Eastern Hospital
    • Contact: Guanghua YANG, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMDENDRIM	Device: IMDENDRIM; In situ and intra tumoral injection of non removal nanodevice IMDENDRIM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: French Association for the Advancement Medical Research
• Collaborators: Shanghai Tongji Hospital, Tongji University School of Medicine
• Investigators: Study Director: Bertrand NASSAR, MD, PhD, AFPREMED

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Anticipated): October 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: AFPREMED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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