Clinical trial · Interventional

Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Intrahepatic Vessels

To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant

NCT03063840CI-TRIAL-00048421withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): NO participants enrolled

Summary

Brief summary (as posted)

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.

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 (1)

Intervention	Type	Mapped drug	Match
Microwave ablation	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Microwave ablation (MWA)
description
Microwave ablation (MWA)
interventionNames
1. Device: Microwave ablation

Primary outcomes (1)

measure
tumor evaluation
timeFrame
1 month after treatment
description
Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

Secondary outcomes (5)

measure
Eastern Cooperative Oncology Group (ECOG) evaluation
timeFrame
up to two years
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for this study:

1. Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
2. Have at least one, but less than or equal to 3 tumors.
3. Each tumor must be ≤ 5 cm in diameter.
4. Child-Pugh class A-B.
5. Eastern Cooperative Oncology Group (ECOG) score of 0-1.
6. American Society of Anaesthesiologists (ASA) score ≤ 3.
7. Adequate bone marrow and liver function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 2 mg/dL(3). alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal (4). prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0.
8. The disease status is not suitable to receive transarterial chemoembolization or other standard treatment.
9. Prior Informed Consent Form.
10. Life expectancy of at least 3 months.

Exclusion Criteria:

Patients presenting with any of the following will not be enrolled into this study:

1. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
2. Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation.
3. Patients who cannot tolerate radiofrequency ablation (RFA) procedure.
4. Known history of human immunodeficiency virus (HIV) infection.
5. Concurrent extrahepatic cancer.

References

Publications (0)

Data not yet available

No reference posted for this study.