Cosiporfin Sodium for Injection Photodynamic Therapy

NCT07398339 | Recruiting Phase 2

• 1 other identifier: GS101-BTC-II-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Biliary Tract Cancers (BTC)

Outcome Measures

Primary Outcomes (1)

• 6-month overall survival rate (6m-OS rate)

  Month 6

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Month 12&Month 24

• Disease Control Rate (DCR)

  Month 12&Month 24

• Progression-Free Survival (PFS)

  Month 12&Month 24

• Duration of Response (DoR)

  Month 12&Month 24

• Overall Survival (OS)

  Month 12&Month 24

Study Arms (1)

Cosiporfin Sodium for injection Combination Therapy Group

EXPERIMENTAL

Cosiporfin Sodium for injection Photodynamic Therapy Combined with Gemcitabine and Cisplatin Chemotherapy

Drug: Cosiporfin Sodium for injection, DVDMS; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for injection

Interventions

Gemcitabine Hydrochloride for Injection DRUG

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

Cosiporfin Sodium for injection Combination Therapy Group

Cisplatin for injection DRUG

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

Cosiporfin Sodium for injection Combination Therapy Group

Cosiporfin Sodium for injection, DVDMS DRUG

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

Cosiporfin Sodium for injection Combination Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Subjects with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);
• Subjects with an expected survival of ≥3 months;
• 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);
• Coagulation Function: International Normalized Ratio (INR) ≤1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN;
• Echocardiogram: Left ventricular ejection fraction (LVEF) ≥50%;
• lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \<470 msec (Appendix 4);
• Recovered from all prior treatments with toxicities resolved to Grade 1 or below;
• Female subjects of childbearing potential and all male subjects must agree to use highly effective contraception during the trial and for 6 months after the last dose of sodium porphyrin. contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptives, subcutaneous implant, etc.), and women of childbearing potential must have a negative pregnancy test result within ≤7 days prior to study drug administration.

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible for enrollment:
• 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);
• 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;
• Previous exposure to photosensitizers or photodynamic therapy;
• Patients with unremovable stents in the extrahepatic bile ducts;
• 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;
• Subjects who underwent major surgery within 4 weeks prior to study drug administration;
• Subjects who used Chinese herbal medicines with immunomodulatory or antitumor effects within 14 days prior to study drug administration;
• Subjects with advanced cholangiocarcinoma in a cachectic state or who are not expected to tolerate photodynamic therapy;
• Patients with Bismuth Type IV hilar cholangiocarcinoma;
• Individuals unsuitable for ERCP or endoscopic procedures;
• Subjects requiring concomitant antitumor therapy during study drug treatment, including chemotherapy regimens other than GC, radiotherapy, immunotherapy, or biologic agents;

Sponsors & Collaborators

• Shanghai Guangsheng Biopharmaceutical Co., Ltd: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

No. 266, Trumpet Vine Road

Shanghai, Pudong New Area, 200120, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Injections; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

yu xin Xue

CONTACT

13151915398; xinyu.xue@shgsmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 9, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)