Clinical trial · Interventional
Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
- 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™ system is safe and effective in combination with chemotherapy 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 * 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 may be eligible * Must have recovered from the toxicity from any prior antineoplastic therapy Exclusion Criteria: * 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 (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN * Total bilirubin greater than 1.5 X ULN * Serum creatinine greater than 2.5 X ULN * Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)
References
Publications (2)
- 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
- 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