Clinical trial · Interventional
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Pharmacokinetics of Doxorubicin in Conventional Transarterial Chemoembolization (cTACE) of Primary and Secondary Liver Cancer
- 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)
Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. Doxorubicin is a chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive super-selective CTACE (i.e., delivered in close proximity to the tumor).
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| superselective cTACE doxorubicin | Drug | — | UNRESOLVED |
| whole liver lobe cTACE doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- whole liver lobe cTACE doxorubicin
- description
- Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via cTACE delivered in a lobar (whole liver) manner.
- interventionNames
- Drug: whole liver lobe cTACE doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- superselective cTACE doxorubicin
- description
- Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via cTACE delivered in a super-selective (close to the tumor) manner.
- interventionNames
- Drug: superselective cTACE doxorubicin
Primary outcomes (5)
- measure
- Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically, cytologically, or radiologically confirmed liver dominant or liver only malignancy. 3. Preserved liver function (Child-Pugh A-B class) without significant liver decompensation. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry. 5. Measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). 6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and international normalized ratio. 7. May be enrolled with a history of prior liver directed intra-arterial therapy if intra-arterial therapy to the target lesion occured \> 1 year prior to enrollment date. Intra-arterial therapy to different targets within 1 year prior to enrollment date will not exclude subjects. Exclusion Criteria: 1. Serum total bilirubin \> 3.0 mg/dL 2. Creatinine \> 2.0 mg/dL 3. Platelets \< 50000/µL 4. Complete portal vein thrombosis with reversal of flow 5. Ascites (trace ascites on imaging is acceptable)
References
Publications (1)
- DERIVEDSavic LJ, Chapiro J, Funai E, Bousabarah K, Schobert IT, Isufi E, Geschwind JH, Stark S, He P, Rudek MA, Perez Lozada JC, Ayyagari R, Pollak J, Schlachter T. Prospective study of Lipiodol distribution as an imaging marker for doxorubicin pharmacokinetics during conventional transarterial chemoembolization of liver malignancies. Eur Radiol. 2021 May;31(5):3002-3014. doi: 10.1007/s00330-020-07380-w. Epub 2020 Oct 15. PMID 33063185