Clinical trial · Interventional
Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria
Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
NCT01141478CI-TRIAL-00054497HCCterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to low enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Proton Beam Radiotherapy plus Sorafenib
- description
- 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.
- interventionNames
- Radiation: Proton Beam Radiotherapy
- Drug: Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Overall Survival Rate Between Time of Consent and Time of Death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.