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NCT00355355
A Phase 3 Randomized Study to Evaluate Survival of Patients Treated With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Phase 3 trial testing Talaporfin sodium in Carcinoma, Hepatocellular in 208 participants. Completed in 1 September 2012.
1 September 2012
Quick facts
| Lead sponsor | Light Sciences Oncology |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 208 |
| Start date | 1 July 2006 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 September 2012 |
| Sites | 34 locations across Croatia, Hong Kong, India, Malaysia, Philippines, Poland, Serbia, Singapore |
Drugs / interventions tested
- Talaporfin sodium — full drug profile →
- Interstitial Light Emitting Diodes
- Percutaneous placement of device in the liver
- Standard Care — full drug profile →
Conditions studied
- Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
- Liver Neoplasms — all drugs for Liver Neoplasms →
Sponsor
Light Sciences Oncology — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Hepatocellular or Liver Neoplasms. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall survival
Time frame: 130 weeks
Sponsor's own description
The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Radiofrequency ablation: mechanisms and clinical applications.
Wu J, Zhou Z, Huang Y, Deng X, et al · · 2024 · cited 24× · PMID 39359691 · DOI 10.1002/mco2.746
Verify or expand the search:
- PubMed search for NCT00355355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00355355 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Light Sciences Oncology
- Last refreshed: 22 January 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00355355.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing