Clinical trial · Interventional
Treatment of Non-responding to Conventional Therapy Inoperable Liver Cancers by in Situ Introduction of ImDendrim
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"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy and Safety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMDENDRIM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMDENDRIM
- interventionNames
- Device: IMDENDRIM
Primary outcomes (1)
- measure
- size of tumor
- timeFrame
- 12 weeks
- description
- evaluation criteria for solid tumors RECIST
Secondary outcomes (2)
- measure
- Progression free survival PFS
- timeFrame
- 12 weeks
- description
- PFS-end-point was defined as either Imaging progression or death of any cause
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
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