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

Efficacy and Safety Clinical Trial

— 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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03255343
• Other study ID #: AFPREMED
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 18, 2017
• Start date: March 13, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: French Association for the Advancement Medical Research
• Contact: HAFID BELHADJ-TAHAR, MD, PhD
• Phone: 00336467722224
• Email: belhadj-tahar[@]afpremed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy and Safety
• Liver Neoplasms

Intervention

Device:
• IMDENDRIM
In situ and intra tumoral injection of non removal nanodevice IMDENDRIM

Locations

Country	Name	City	State
China	Tongji University Eastern Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
French Association for the Advancement Medical Research	Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of tumor	evaluation criteria for solid tumors RECIST	12 weeks
Secondary	Progression free survival PFS	PFS-end-point was defined as either Imaging progression or death of any cause	12 weeks
Secondary	HPFS	Hepatic free survival	12 weeks