Status:
UNKNOWN
Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim
Lead Sponsor:
French Association for the Advancement Medical Research
Collaborating Sponsors:
Shanghai Tongji Hospital, Tongji University School of Medicine
Conditions:
Efficacy and Safety
Eligibility:
All Genders
18-75 years
Phase:
NA
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-label...
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 coup...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- Any metastasis no located in liver (liver tumor extended without discontinuity to other regional structures are accepted, see inclusion criteria).
- 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.
Key Trial Info
Start Date :
March 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03255343
Start Date
March 13 2017
End Date
December 31 2017
Last Update
August 21 2017
Active Locations (1)
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1
Tongji University Eastern Hospital
Shanghai, China