N/A
N=109
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Localized Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03113955 ↗Enrolled (actual)
109
Serious AEs
12.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging) — 75; 73 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tandem Microsphere loaded with Epirubicin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Varian Medical Systems
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging) |
75; 73 | — |
| SECONDARY Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months |
10; 8 | — |
| SECONDARY Number of Participants With Objective Tumor Response at 30-day |
86; 86 | — |
| SECONDARY Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months |
10; 8 | — |
| SECONDARY Kaplan-Meier Analyses the Percent of Participants for Overall Survival |
100 | — |
| SECONDARY Number of Adverse Events Relate to Study Device in 12 Months Post Procedure |
17; 301 | — |
| SECONDARY Number of Participants With Objective Tumor Response at 3 Months |
84; 85 | — |
| SECONDARY Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread |
20 | — |
Summary
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria
- Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
- Male or female of age ≥18 and ≤75 years.
- Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
- HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
- Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter 50% liver involvement , or arteriovenuous fistula
- Macrovascular invasion of main or primary branches of portal vein at entry into the study
- Any contraindication for TACE treatment
- Any contraindication for Epirubicin administration
- Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal)
- Renal failure or insufficient renal function (Creatinine levels >2 mg/dl)
- Subject unable to receive MRI examination
- Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
- couldn't commit reliable birth control measures during treatment or within 12 months of treatment
- Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
- Subject is not suitable to participate in the study as judged by investigator
Data sourced from ClinicalTrials.gov (NCT03113955). 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.