SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT02221778
• Date of registration: 19/08/2014
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo
• Public title: SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE
• Scientific title: Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization
• Date of first enrolment: August 2014
• Target sample size: 25
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02221778
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Flair J Carrilho, MD, PhD
• Affiliation: University of Sao Paulo

• Name: Andre T Chen, MD, PhD
• Affiliation: University of Sao Paulo

Key inclusion & exclusion criteria

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

- Child-Pugh A or absence of hepatic cirrhosis

- absence of encephalopathy or ascitis on clinical exam

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Lab exams:

- hemoglobin > or equal 8 mg/dl

- neutrophils > or equal 1.200/mm³

- platelets > or equal 45.000/mm³

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times
the upper normal limit

- bilirubin equal or < 2 mg/dl

- international normalized ratio (INR) < 1.7

- serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance >
or equal 60 ml/min

- Albumin >2.8 mg/dl

- not being pregnant - a negative pregnancy test is required (for women). Patients in
fertile age should use a contraceptive method during treatment and 4 months after.

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

- Patients unable to understand and sign written informed consent



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Hepatocellular

Intervention(s)

Radiation: SBRT

Primary Outcome(s)

Local Progression Free Survival [Time Frame: 5 years]

Secondary Outcome(s)

Distant Progression Free Survival [Time Frame: 5 years]

Toxicity [Time Frame: 5 years]

Overall Survival [Time Frame: 5 years]

Secondary ID(s)

RT-02/2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors