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

• Sponsor: French Association for the Advancement Medical Research (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03255343
• Collaborator: Shanghai Tongji Hospital, Tongji University School of Medicine (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.6
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy and Safety	Device: IMDENDRIM	N/A

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.

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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 cm²10 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)
• Primary Purpose: Treatment
• 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"
• Actual Study Start Date: Mar 13, 2017
• Anticipated Primary Completion Date: Oct 31, 2017
• Anticipated Study Completion Date: Dec 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. size of tumor [12 weeks]

   evaluation criteria for solid tumors RECIST

Secondary Outcome Measures

1. Progression free survival PFS [12 weeks]

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

2. HPFS [12 weeks]

   Hepatic free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji University Eastern Hospital	Shanghai		China

Sponsors and Collaborators

• French Association for the Advancement Medical Research
• Shanghai Tongji Hospital, Tongji University School of Medicine

Investigators

• Study Director: Bertrand NASSAR, MD, PhD, AFPREMED

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: French Association for the Advancement Medical Research
• ClinicalTrials.gov Identifier: NCT03255343
• Other Study ID Numbers: AFPREMED
• First Posted: Aug 21, 2017
• Last Update Posted: Aug 21, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

No Results Posted as of Aug 21, 2017