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SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE | Clinical Trials | Clareo Health

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SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization

NCT02221778•University of Sao Paulo

View on ClinicalTrials.gov

Summary

This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
•Tumor Stage
•liver only disease
•tumor thrombus at segment is allowed
•no extra hepatic metastases
•tumor encompassing less than 50% of hepatic volume
•previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
•presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
•Maximum lesion size of 10 cm.
•Liver residual volume equal or more than 700cc or 40% of total liver volume
+13 more criteria

Exclusion Criteria

•Patients with more than 5 discrete lesions in the liver
•Main or common biliary duct invasion
•Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
•Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
•Previous radiation to upper abdomen
•Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
•Patients with ischemic myocardial infarction within the last 6 months
•Patients with large esophageal varices with red color sign or bleeding within the last 3 months
•Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
•Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
+1 more criteria

Locations (1)

Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil

Key Dates

Start Date

August 1, 2014

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

December 6, 2024

Enrollment

ESTIMATED participants

Conditions

Carcinoma, Hepatocellular

Interventions

SBRT

RADIATION

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

NCT06454578

Carcinoma, Hepatocellular

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RECRUITING

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Inclusion Criteria

Exclusion Criteria

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

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