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

NCT03255343 | Unknown DMC

• 1 other identifier: AFPREMED
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

• size of tumor

  evaluation criteria for solid tumors RECIST

  12 weeks

Secondary Outcomes (2)

• Progression free survival PFS

  12 weeks

• HPFS

  12 weeks

Study Arms (1)

IMDENDRIM

EXPERIMENTAL

Device: IMDENDRIM

Interventions

IMDENDRIM DEVICE

In situ and intra tumoral injection of non removal nanodevice IMDENDRIM

IMDENDRIM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tongji University Eastern Hospital

Shanghai, China

RECRUITING

Study Officials

• Bertrand NASSAR, MD, PhD

  AFPREMED

  STUDY DIRECTOR

Central Study Contacts

HAFID BELHADJ-TAHAR, MD, PhD

CONTACT

00336467722224; belhadj-tahar@afpremed.org

Nouredine SADEG, PhD

CONTACT

0033679343657; nouredinesadeg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 patients with liver tumor non operable, with resistance to other classical chemotherapy, injected a single dose of IMDENDRIM 10 mCi per 1 cm²

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 21, 2017
• Study Start: March 13, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

CN (1)