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Trial record 1 of 1 for:    NCT01141478
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Proton Beam Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Loma Linda University
Information provided by (Responsible Party):
Michael Devera, MD, Loma Linda University Identifier:
First received: May 24, 2010
Last updated: November 2, 2016
Last verified: November 2016
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

Condition Intervention
Carcinoma, Hepatocellular
Radiation: Proton Beam Radiotherapy
Drug: Sorafenib

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

Resource links provided by NLM:

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: On average followed for 5 years ]

Secondary Outcome Measures:
  • To assess the radiological progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: On average followed for 5 years ]

Estimated Enrollment: 220
Study Start Date: August 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Proton Beam Radiotherapy plus Sorafenib
A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
Radiation: Proton Beam Radiotherapy
Fifteen consecutive sessions
Drug: Sorafenib
400 mg po bid
Active Comparator: Sorafenib
Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Drug: Sorafenib
400 mg po bid


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients are candidates to receive both proton beam and sorafenib
  2. Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

  1. Patients who are candidates for surgical resection
  2. Patients with tumor burden within Milan and/or San Francisco criteria
  3. Patients who have contraindication to receive proton
  4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
  5. Patients treated previously by any locoregional treatment
  6. Patients with prior liver transplant
  7. Patients with child class C
  8. Patients with model for end-stage liver disease (MELD) score of > 25
  9. Patients with other comorbid diseases that may impact survival
  10. Patients with ongoing alcohol intake
  11. Patients with active sepsis
  12. Patients with gastrointestinal bleeding within a week
  13. Patients unwilling to sign informed consent form
  14. Patients with history of noncompliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01141478

Contact: Diane Scavone 909-558-3636

United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Principal Investigator: Michael deVera, MD Loma Linda University Medical Center
  More Information

Responsible Party: Michael Devera, MD, Medical Doctor, Loma Linda University Identifier: NCT01141478     History of Changes
Other Study ID Numbers: 5100104
Study First Received: May 24, 2010
Last Updated: November 2, 2016

Keywords provided by Loma Linda University:
Carcinoma, Hepatocellular
Proton Beam Radiotherapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on May 23, 2017