A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma
This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally
advanced HCC. Patients whose tumor(s) are not suitable for other local treatment, such as
surgery, trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency
ablation. will be enrolled.Radical radiotherapy will be started after pre-treatment
evaluation. The total dose of RT will be 50Gy in 25 fractions to local tumor(s). Oral
Thalidomide will be started 3 days before RT begins. Thalidomide treatment will continue for
totally 6 months or until tumor progression. Dynamic contrast enhanced MRI (DCEMRI) will be
done at the following time points to assess the change in tumor perfusion: (1) before the
start of thalidomide treatment; (2) 3 days after thalidomide before radiotherapy; (3) 2weeks
after radiotherapy begins;and (4) 1 month after radiotherapy completes. DCEMRI will then be
done every 3 months until disease progression.Serum samples for angiogenic cytokine studies
will also be collected.The study was designed to evaluate the feasibility and tolerability
of combination treatment of radiotherapy and thalidomide for locally advanced HCC. The
sample size was determined by the expected incidence of grade 4 toxicity of the combination
treatment versus radiotherapy alone for locally advanced HCC. Since the grade 4 toxicity of
radiotherapy alone is 7-9%, we need at least 15 patients to evaluate for feasibility of the
combination treatment. With an estimated drop out rate of approximately 10%, 17 patients
will be enrolled.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the feasibility and tolerability of thalidomide plus radiotherapy.
Hui-Ju Ch'ang, M.D.
National Health Research Institutes, Division of Cancer Research
Taiwan: Department of Health