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
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Shanghai Guangsheng Biopharmaceutical Co., Ltd
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 6-month overall survival rate (6m-OS rate)
Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be enrolled in this study:
- •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);
Exclusion Criteria
- •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;
Arms & Interventions
Cosiporfin Sodium for injection Combination Therapy Group
Cosiporfin Sodium for injection Photodynamic Therapy Combined with Gemcitabine and Cisplatin Chemotherapy
Intervention: Cosiporfin Sodium for injection, DVDMS (Drug)
Cosiporfin Sodium for injection Combination Therapy Group
Cosiporfin Sodium for injection Photodynamic Therapy Combined with Gemcitabine and Cisplatin Chemotherapy
Intervention: Gemcitabine Hydrochloride for Injection (Drug)
Cosiporfin Sodium for injection Combination Therapy Group
Cosiporfin Sodium for injection Photodynamic Therapy Combined with Gemcitabine and Cisplatin Chemotherapy
Intervention: Cisplatin for injection (Drug)
Outcomes
Primary Outcomes
6-month overall survival rate (6m-OS rate)
Time Frame: Month 6
Secondary Outcomes
- 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)
- 12/24-Month Survival Rate(Month 12&Month 24)
- Time to First Chemotherapy(Month 12&Month 24)
- Time to Jaundice Recurrence/Recurrence Rate(Month 12&Month 24)