Cosiporfin Sodium for Injection Photodynamic Therapy
ConditionBiliary Tract Cancers (BTC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Guangsheng Biopharmaceutical Co., Ltd
About this trial
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)
Eligibility criteria
Qualifiers
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;
Disqualifiers
Patients with ampullary cancer;
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);
Trial design
Treatments tested in this trial
- Cosiporfin Sodium for injection, DVDMS
- Gemcitabine Hydrochloride for Injection
- Cisplatin for injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanghai Guangsheng Biopharmaceutical Co., Ltd
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Source ClinicalTrials.gov