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

NCT ID: NCT01141478

Last Updated: 2021-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-08

Study Completion Date

2016-06-10

Brief Summary

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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

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Proton Beam Radiotherapy

Intervention Type RADIATION

Fifteen consecutive sessions

Sorafenib

Intervention Type DRUG

400 mg po bid

Sorafenib

Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

400 mg po bid

Interventions

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Proton Beam Radiotherapy

Fifteen consecutive sessions

Intervention Type RADIATION

Sorafenib

400 mg po bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael deVera, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5100104

Identifier Type: -

Identifier Source: org_study_id