Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria (HCC)

Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Radiation: Proton Beam Radiotherapy; Drug: Sorafenib

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate Between Time of Consent and Time of Death	All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.	Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael deVera, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2010
• Primary Completion (Actual): December 26, 2014
• Study Completion (Actual): June 10, 2016

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Sorafenib; Carcinoma, Hepatocellular; Proton Beam Radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 5100104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes