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Maintenance of Sorafenib Following Combined Therapy of Three-dimensional Conformal Radiation Therapy/Intensity-modulated Radiation Therapy and Transcatheter Arterial Chemoembolization in Patients With Locally Advanced Hepatocellular Carcinoma: a Phase I/II Study.


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Maintenance of Sorafenib Following Combined Therapy of Three-dimensional Conformal Radiation Therapy/Intensity-modulated Radiation Therapy and Transcatheter Arterial Chemoembolization in Patients With Locally Advanced Hepatocellular Carcinoma: a Phase I/II Study.


Patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically
confirmed HCC receive TACE (1-3 cycles) plus 3DCRT/IMRT 4-6 weeks later. Maintenance
Sorafenib will be administered only for the patients with non-progression disease 4 to 6
weeks after the completion of radiotherapy. The dose will be 400 mg, p.o., twice a day.
Sorafenib will be continuously given for 12 months unless intolerable toxicities and/or
tumor progression. Hypothesis of the current study is that Sorafenib as a maintenance
therapy after combined therapy of 3DCRT/IMRT and TACE is safe and superior to radiotherapy
combined with TACE alone in terms of time to progression (TTP), progression-free survival
(PFS) and overall survival (OS) in comparison to historical data.


Inclusion Criteria:



1. Age of equal or older than 18 years and not over 75 years with a life expectancy of
at least 12 weeks;

2. Karnofsky performance status (KPS) of ≥70;

3. Histologically or cytologically confirmed HCC;

4. BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less
than 50% of total liver volume;

5. Liver function of Child-Pugh A;

6. Technically unresectable, medically inoperable, or surgery declined by the patient;

7. Normal renal function and adequate bone marrow reservation;

8. Signed informed consent must be obtained prior to any study specific procedure.

Exclusion Criteria:

1. Presence of intrahepatic and/or extrahepatic metastases

2. Previous received systemic therapy for liver cancer;

3. History of radiotherapy to the liver;

4. Indistinct tumor boundary on CT/MRI images;

5. Previous or concurrent malignancies, with the exception of adequately treated basal
cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder
tumors [Ta, Tis and T1];

6. History of cardiac disease: congestive heart failure > NYHA class 2, active CAD,
cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension
within the last 12 months;

7. Concurrent uncontrolled medical conditions;

8. Pregnancy or breast feeding;

9. Investigational drug therapy outside of this trial during or within 4 weeks of study
entry;

10. Psychiatric or medical unstable conditions that compromise the patient's ability to
give informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The safety and tolerability of maintenance Sorafenib.

Outcome Time Frame:

twelve months

Safety Issue:

Yes

Principal Investigator

Guo-liang Jiang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Food and Drug Administration

Study ID:

LCR-004

NCT ID:

NCT00999843

Start Date:

October 2009

Completion Date:

October 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Sorafenib
  • Three-dimensional conformal radiation therapy
  • Intensity-modulated radiation therapy
  • Transcatheter arterial chemoembolization
  • Carcinoma
  • Carcinoma, Hepatocellular

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