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PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

NCT04099888 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-09-11

Study results available
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Summary

This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

Conditions

Interventions

DRUG

Fimaporfin and Gemcitabine

PCI treatment consists of IV administration of Amphinex solution for injection (investigational product) at 0.22 mg/kg dose of fimaporfin, followed 4 days later by a standard dose of gemcitabine infusion (1000 mg/m²) and intraluminal laser light application. Up to 2 PCI treatments will be given.

DRUG

Gemcitabine/Cisplatin chemotherapy

Up to 8 cycles of gemcitabine/cisplatin combination chemotherapy will be administered.

Sponsors & Collaborators

  • PCI Biotech AS

    lead INDUSTRY

Principal Investigators

  • PCI Biotech · PCI Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2022-04-28
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Norway
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04099888 on ClinicalTrials.gov