Clinical Trial

Cosiporfin Sodium for Injection Photodynamic Therapy

Study acronym: DVDMS
Recruiting Phase 2
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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)
Trial Details
NCT Number NCT07398339
Lead Sponsor Shanghai Guangsheng Biopharmaceutical Co., Ltd
Collaborators: Peking University Cancer Hospital & Institute
Conditions Biliary Tract Cancers (BTC)
Enrollment 30 participants
Start Date 2026-03-31
Primary Completion 2027-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-09