OncoMatch/Clinical Trials/NCT07398339
Cosiporfin Sodium for Injection Photodynamic Therapy
Is NCT07398339 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cosiporfin Sodium for and Gemcitabine Hydrochloride for for biliary tract cancers (btc).
Treatment: Cosiporfin Sodium for · Gemcitabine Hydrochloride for · Cisplatin for — 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)
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy (anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies)
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.)
Cannot have received: chemotherapy (gemcitabine, cisplatin)
Patients with prior history of ... gemcitabine, or cisplatin treatment
Cannot have received: photosensitizer or photodynamic therapy
Previous exposure to photosensitizers or photodynamic therapy
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L (1500/mm³); platelets ≥100 × 10⁹/L (1 × 10⁵/mm³); hemoglobin ≥9.0 g/dL (no treatment for bone marrow suppression within 14 days prior to screening)
Kidney function
Creatinine clearance (Ccr) ≥50 mL/min (Cockcroft-Gault formula)
Liver function
No severe hepatic impairment (Child-Pugh Class C), hemorrhagic disorders secondary to hepatic insufficiency, or hepatic encephalopathy
Cardiac function
LVEF ≥50%; QTcF <470 msec; no clinically significant cardiovascular disease or conditions as detailed in exclusion criteria
Adequate organ and bone marrow function: ANC ≥1.5 × 10⁹/L; platelets ≥100 × 10⁹/L; hemoglobin ≥9.0 g/dL; Creatinine clearance ≥50 mL/min; INR ≤1.5 × ULN; APTT ≤1.5 × ULN; LVEF ≥50%; QTcF <470 msec; see exclusion for cardiac details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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