Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cosiporfin Sodium for injection, DVDMS

    Drug

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

  • Gemcitabine Hydrochloride for Injection

    Drug

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

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cosiporfin Sodium for injection Combination Therapy GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Month 6

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Month 12&Month 24
2

Disease Control Rate (DCR)

Time frame
Month 12&Month 24
3

Progression-Free Survival (PFS)

Time frame
Month 12&Month 24
4

Duration of Response (DoR)

Time frame
Month 12&Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Guangsheng Biopharmaceutical Co., Ltd

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov
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