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Cosiporfin Sodium for Injection Photodynamic Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07398339•Shanghai Guangsheng Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. All subjects or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any screening procedures;
•2. Age ≥ 18 years, no gender restrictions;
•3. Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery;
•4. No prior systemic therapy during the recurrent or metastatic stage;
•5. 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;
•6. Subjects with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);
•7. Subjects with an expected survival of ≥3 months;
•8. Subjects with adequate organ and bone marrow function meeting the following laboratory criteria:
•* Bone marrow function: Absolute neutrophil count (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, such as GCS-F, EPO, or blood transfusion, within 14 days prior to screening laboratory tests);
•* Renal Function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 4);
+5 more criteria

Exclusion Criteria

•Subjects meeting any of the following criteria are ineligible for enrollment:
•1. Patients with ampullary cancer;
•2. Known hypersensitivity to sodium porphyrin or other photosensitizing agents;
•3. Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;
•4. Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately treated);
•5. 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;
•6. Previous exposure to photosensitizers or photodynamic therapy;
•7. Patients with unremovable stents in the extrahepatic bile ducts;
•8. 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;
•9. Subjects who underwent major surgery within 4 weeks prior to study drug administration;
+28 more criteria

Locations (1)

No. 266, Trumpet Vine Road

Shanghai, Pudong New Area, China

Key Dates

Start Date

March 31, 2026

Primary Completion Date

March 31, 2027

Completion Date

March 31, 2028

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

Biliary Tract Cancers (BTC)

Interventions

Cosiporfin Sodium for injection, DVDMS

DRUG

Gemcitabine Hydrochloride for Injection

DRUG

Cisplatin for injection

DRUG

Contacts

yu xin Xue

CONTACT

13151915398 xinyu.xue@shgsmed.com

TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort

NCT07454486

Biliary Tract Cancer (BTC)Biliary Tract Cancer (CCA)+12 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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