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Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Phase 1
18 Years
75 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Inclusion Criteria:

- Pathologically confirmed or clinically diagnosed HCC

- Surgically unsectable or medically inoperable diseases, or surgery declined by the

- Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic
and/or distant metastases

- Associated with cirrhosis of Child-Pugh A

- Karnofsky performance status (KPS) of ≥ 70

- Normal renal function and adequate bone marrow reservation

- Tolerate active breathing control (ABC)

Exclusion Criteria:

- Child-Pugh B or C liver cirrhosis score

- Previous radiotherapy to the liver

- Indistinct tumor boundary in CT/MRI image

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Guoliang Jiang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

May 2008

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • radiation therapy
  • 3-dimensional conformal radiation therapy (3-DCRT)
  • intensity modulated radiation therapy (IMRT)
  • active breathing control
  • Carcinoma
  • Carcinoma, Hepatocellular