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

Not Applicable

• Conditions: Efficacy and Safety
• Interventions: Device: IMDENDRIM

• Registration Number: NCT03255343
• Lead Sponsor: French Association for the Advancement Medical Research

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:

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 Timeline

• Study Start: 2017-03-13
• Status Verified: 2017-08
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-18
• Last Update Submitted: 2017-08-18
• Study First Posted: 2017-08-21
• Last Update Posted: 2017-08-21
• Primary Completion: 2017-10-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMDENDRIM	IMDENDRIM	-

Primary Outcome Measures

Name	Time	Method
size of tumor	12 weeks	evaluation criteria for solid tumors RECIST

Secondary Outcome Measures

Name	Time	Method
Progression free survival PFS	12 weeks	PFS-end-point was defined as either Imaging progression or death of any cause
HPFS	12 weeks	Hepatic free survival

Trial Locations

Locations (1)

Tongji University Eastern Hospital; 🇨🇳 Shanghai, China