RecruitingPhase 2NCT07398339

Cosiporfin Sodium for Injection Photodynamic Therapy

A Multicenter, Open-Label, Phase IIa Clinical Study Evaluating the Preliminary Efficacy and Safety of Sodium Porphyrin Injection Combined With Photodynamic Therapy Plus Gemcitabine and Cisplatin Chemotherapy in Patients With Advanced Extrahepatic Cholangiocarcinoma With Biliary Obstruction


Sponsor

Shanghai Guangsheng Biopharmaceutical Co., Ltd

Enrollment

30 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called photodynamic therapy (PDT) using a drug called cosiporfin sodium — where a light-sensitive drug is injected into the body and then activated by a special light to destroy cancer cells — for patients with advanced bile duct cancer (cholangiocarcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic bile duct cancer outside the liver (extrahepatic cholangiocarcinoma) that is inoperable - You have not received prior chemotherapy or immunotherapy for advanced disease - You are in good functional health (ECOG 0 or 1) - You have at least one measurable tumor **You may NOT be eligible if...** - You have previously received photodynamic therapy or photosensitizing drugs - Your cancer has spread extensively to the liver (over 50% of liver affected) - You have brain metastases - You have active hepatitis B, C, HIV, or syphilis - You have serious heart, kidney, or blood clotting problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCosiporfin Sodium for injection, DVDMS

Dosage: 0.2 mg/kg Storage: 2-8°C. Protect from light. Specifications: 10mg per bottle

DRUGGemcitabine Hydrochloride for Injection

Specifications: 1.0g/vial, 5 vials/box Storage: Store at room temperature (15-30°C) Dosage: 1000mg/m²

DRUGCisplatin for injection

Specifications: 20mg/vial, 8 vials/box Storage: Store in a light-protected, tightly closed container (10-30°C) Dosage: 25mg/m²


Locations(1)

No. 266, Trumpet Vine Road

Shanghai, Pudong New Area, China

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NCT07398339


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