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A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

Phase 1/Phase 2
20 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

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.

Inclusion Criteria:

- 1.1 Patients with measurable, locally advanced HCC that are not suitable for other
local therapies, including surgery, TAE, alcohol injection, or radiofrequency

1.2 Patients with histological confirmed HCC or patients who do not have histological
diagnosis but have met all of the following criteria: 1.2.1 Presence of chronic viral
hepatitis and/or cirrhosis 1.2.2 Presence of hepatic tumor(s) with image findings
(sonography, CT scan) compatible with HCC.

1.2.3 A persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence
of ana-fetoprotein-secreting germ cell tumor.

1.3 Patients without any local or systemic therapy for HCC within 4 weeks. 1.4 Patients
with age > 20 years and < 70 years. 1.5 Patients with a performance status of ECOG score <
1. 1.6 Patients must fulfill all of the following criteria: 1.6.1 Child-Pugh’s Score ≦ 7.
1.6.2 Serum total bilirubin < 1.5 times upper normal limit (UNL 1.6.3 Serum alanine
transaminase (ALT) < 5 times UNL 1.6.4 Platelet count > 5.0 x 104 / mm3. 1.6.5 White blood
cell count > 3,000 / mm3. 1.6.6 Serum creatinine < 2.0 mg/dL 1.7 Patient must have local
tumors less than one half of the whole liver and the tumors can be encompassed within RT
fields 1.8 Signed informed consent 1.9 Sexually active patients, in conjunction with their
partner, must practice birth control during, and for 2 months after, thalidomide therapy.

1.10 Female patients in child-bearing age must have negative pregnancy test.

Exclusion Criteria:

- 2.1. Patients with documented extrahepatic metastasis. 2.2. Patients who received
previous radiotherapy to abdominal area. 2.3. Patients who have received thalidomide
treatment prior to enrollment. 2.4. Patients who had other investigational drug
treatment within 4 weeks prior to enrollment.

2.5. Patients with NCI grade 2 or greater peripheral neuropathy of any causes. 2.6.
Patients with other systemic diseases that required concurrent usage of
glucocorticosteroid or immunosuppressant agent(s).

2.7. Patients who have major systemic diseases that the attending physicians consider
inappropriate for radiotherapy or thalidomide therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the feasibility and tolerability of thalidomide plus radiotherapy.

Principal Investigator

Hui-Ju Ch'ang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Health Research Institutes, Division of Cancer Research


Taiwan: Department of Health

Study ID:




Start Date:

March 2005

Completion Date:

August 2005

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Radiotherapy
  • Thalidomide
  • Dynamic contrast enhanced MRI
  • Carcinoma
  • Carcinoma, Hepatocellular