NCT01141478: HCC

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

Terminated NA Results posted Last updated 15 October 2021

What this trial tests

NA trial testing Proton Beam Radiotherapy in Carcinoma, Hepatocellular in 8 participants. Terminated before completion.

Timeline

8 September 2010

Primary endpoint
26 December 2014

10 June 2016

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	8 September 2010
Primary completion	26 December 2014
Estimated completion	10 June 2016
Sites	1 location across United States

Drugs / interventions tested

• Proton Beam Radiotherapy
• Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

• Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →

Sponsor

Loma Linda University

Who can join

Adults 18 to 80, any sex, with Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival Rate Between Time of Consent and Time of Death Primary · 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 onc

Group	Value	95% CI
Proton Beam Radiotherapy Plus Sorafenib	1.6	0.1 – 3.7
Sorafenib	0.36	0.3 – 0.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Proton Beam Radiotherapy Plus Sorafenib

Serious: 1/4 (25%)

Deaths: 3/4

Sorafenib

Serious: 0/4 (0%)

Deaths: 3/4

Serious adverse events (1 terms)

Reaction	System	Proton Beam Radiotherapy P…	Sorafenib
Death - cerebral hemorrahic stroke	General disorders	—	—

Most-reported serious reactions: Death - cerebral hemorrahic stroke.

Data from ClinicalTrials.gov NCT01141478 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proton beam therapy for cancer in the era of precision medicine.
   Hu M, Jiang L, Cui X, Zhang J, et al · · 2018 · cited 57× · PMID 30541578 · DOI 10.1186/s13045-018-0683-4
2. Concurrent versus sequential sorafenib therapy in combination with radiation for hepatocellular carcinoma.
   Wild AT, Gandhi N, Chettiar ST, Aziz K, et al · · 2013 · cited 31× · PMID 23762417 · DOI 10.1371/journal.pone.0065726
3. Leaflet manual of external beam radiation therapy for hepatocellular carcinoma: a review of the indications, evidences, and clinical trials.
   Rim CH, Yoon WS. · · 2018 · cited 25× · PMID 29844684 · DOI 10.2147/ott.s164651
4. Optimal Selection of Radiotherapy as Part of a Multimodal Approach for Hepatocellular Carcinoma.
   Yoon HI, Seong J. · · 2016 · cited 5× · PMID 27386432 · DOI 10.1159/000367762