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Chemotherapy

Gemcitabine/Cisplatin chemotherapy for Bile Duct Cancer (RELEASE Trial)

Phase 2
Waitlist Available
Research Sponsored by PCI Biotech AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights

RELEASE Trial Summary

This trial will compare a new cancer treatment that combines two existing treatments (photochemical internalisation and gemcitabine/cisplatin) to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma.

RELEASE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Adverse Events (AEs)/Serious Adverse Events (SAEs)
Area Under the Plasma Concentration Curve (AUC) Was Performed for Patients in Arm A.
Best Overall Response (BOR)
+9 more

RELEASE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PCI treatment in conjunction with Standard of Care (SoC)Experimental Treatment2 Interventions
Arm A: Fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by gemcitabine/cisplatin chemotherapy
Group II: Standard of Care (SoC)Active Control1 Intervention
Arm B: Gemcitabine/cisplatin chemotherapy

Find a Location

Who is running the clinical trial?

PCI Biotech ASLead Sponsor
5 Previous Clinical Trials
168 Total Patients Enrolled
PCI BiotechStudy DirectorPCI Biotech

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
2019. "PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099888.
~7 spots leftby Apr 2025
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