Cosiporfin Sodium for Injection Photodynamic Therapy
China30 participantsStarted 2026-03-31
Plain-language summary
Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery.
Primary Research Objective: To preliminarily evaluate the efficacy of photodynamic therapy (PDT) with sodium protoporphyrin combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma complicated by biliary obstruction.
Secondary Study Objective: To preliminarily evaluate the safety and tolerability of photodynamic therapy (PDT) with heme porphyrin sodium combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma with biliary obstruction.
Primary endpoint: 6-month overall survival rate (6m-OS rate)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. All subjects or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any screening procedures;
✓. Age ≥ 18 years, no gender restrictions;
✓. Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery;
✓. No prior systemic therapy during the recurrent or metastatic stage;
✓. Presence of obstructive lesions in the extrahepatic bile ducts, with at least one measurable lesion outside the bile ducts according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
✓. Subjects with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);
✓. Subjects with an expected survival of ≥3 months;
✓. Subjects with adequate organ and bone marrow function meeting the following laboratory criteria:
✕. Known hypersensitivity to sodium porphyrin or other photosensitizing agents;
✕. Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;
✕. Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately treated);
✕. Subjects who participated in any other drug clinical trial or other interventional clinical trial within 4 weeks prior to study drug administration, except for subjects participating in observational (non-interventional) clinical studies or those already in the follow-up period of an interventional study;
✕. Previous exposure to photosensitizers or photodynamic therapy;
✕. Patients with unremovable stents in the extrahepatic bile ducts;
✕. Patients with prior history of immunotherapy (including but not limited to various anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, etc.), gemcitabine, or cisplatin treatment;