Phase 2
N=39
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01877187 ↗Enrolled (actual)
39
Serious AEs
28.2%
Results posted
Apr 2020
Primary outcome: Primary: Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) — 1; 1; 17; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipiodol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) |
1; 1; 17; 15; 5; 3 | — |
| PRIMARY Baseline Enhancing Tumor and Response by RECIST Criteria |
95.1; 97.30; 96.2; 53.4; 50.7; 52.1 | .06 |
| SECONDARY Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
9; 2; 9; 12; 6; 3 | — |
| SECONDARY Baseline Enhancing Tumor and Response by mRECIST Criteria |
95.1; 53.7; 78.2; 50.6; 52.7; 50.7 | 0.19 |
| SECONDARY Tumor Response by World Health Organization (WHO) Criteria |
2; 1; 16; 15; 4; 3 | — |
| SECONDARY Baseline Enhancing Tumor and Response by WHO Criteria |
95.1; 97.3; 96.2; 53.4; 50.7; 52.1 | 0.06 |
| SECONDARY Tumor Response by European Association for the Study of the Liver (EASL) Criteria |
11; 2; 7; 12; 7; 5 | — |
| SECONDARY Baseline Enhancing Tumor and Response by EASL Criteria |
77.0; 87.8; 78.2; 50.1; 46.6; 50.1 | 0.020 sig |
| SECONDARY Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria |
6; 1; 10; 13; 5; 4 | — |
| SECONDARY Baseline Enhancing Tumor and Response by qEASL Criteria |
74.1; 81.9; 77.0; 46.0; 50.7; 50.1 | 0.06 |
| SECONDARY 6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE |
67.6 | — |
Summary
The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers).
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Childs class of A or B (up to 9).
- Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).
- Subject is voluntarily participating in the study and has signed the informed consent.
Exclusion Criteria
- Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used).
- Evidence of severe or uncontrolled systemic diseases.
- Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
- Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication).
- Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable.
- Subject is breastfeeding.
- Subject is pregnant
Data sourced from ClinicalTrials.gov (NCT01877187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.