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

Not Applicable

Terminated

• Conditions: Carcinoma, Hepatocellular
• Interventions: Radiation: Proton Beam Radiotherapy; Drug: Sorafenib

• Registration Number: NCT01141478
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2010-09-08
• Primary Completion: 2014-12-26
• Study Completion: 2016-06-10
• Results First Submitted: 2017-09-12
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton Beam Radiotherapy plus Sorafenib	Proton Beam Radiotherapy	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.
Sorafenib	Sorafenib	Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Proton Beam Radiotherapy plus Sorafenib	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate Between Time of Consent and Time of Death	Change between time of informed consent and primary completion date of study, an average of 4 years per participant	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States