Clinical trial · Interventional
Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases
Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the Litx platform is safe and effective in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Metastasis | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Procedure | — | UNRESOLVED |
| LED-based light infusion device | Device | — | UNRESOLVED |
| Light emitting diodes (LED) | Device | — | UNRESOLVED |
| Photodynamic therapy | Procedure | — | UNRESOLVED |
| Phototherapy | Procedure | — | UNRESOLVED |
| Talaporfin sodium (LS11) | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease. * Biopsy proven evidence of colorectal cancer. * Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter. * Age greater than or equal to 18 years. * Patients must be able to sign informed consent. * Life expectancy greater than or equal to 3 months. * ECOG performance status 0-2. * Patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following Litx therapy. * Off chemotherapy for 4 weeks. Must have recovered from the chemotherapy effects. Exclusion Criteria Patients must be excluded if any of the following apply: * Patients who are candidates for complete surgical resection. * Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment. * Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study. * PT or PTT greater than 1.5X control. * Platelet count less than 100,000. * WBC less than 2500/mm. * Neutrophils less than 2000/mm. * Hemoglobin less than 9 g/dL. * Liver enzymes greater than 3 X ULN. * Total bilirubin greater than 1.5 X ULN. * Serum creatinine greater than 2.5 X ULN.
References
Publications (2)
- BACKGROUNDChen J, Keltner L, Christophersen J, Zheng F, Krouse M, Singhal A, Wang SS. New technology for deep light distribution in tissue for phototherapy. Cancer J. 2002 Mar-Apr;8(2):154-63. doi: 10.1097/00130404-200203000-00009. PMID 11999949
- BACKGROUNDLustig RA, Vogl TJ, Fromm D, Cuenca R, Alex Hsi R, D'Cruz AK, Krajina Z, Turic M, Singhal A, Chen JC. A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors. Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708. PMID 14534895