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

Inclusion Criteria:

1. Patients are candidates to receive both proton beam and sorafenib

2. Patients with tumor burden that exceeds San Francisco criteria (Appendix 1)

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 (Appendix 3)

8. Patients with MELD score of > 25 (Appendix 4)

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