Clinical Trials Logo
  1. Home
  2. Cholangiocarcinoma
  3. NCT04099888

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

Cholangiocarcinoma Clinical Trial

Official title:
A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Clinical Trial 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.

Clinical Trial Description

Cholangiocarcinoma (CCA) is an uncommon adenocarcinoma arising from cells lining the bile ducts. Standard treatment options for CCA include surgery, radiotherapy and chemotherapy, dependent upon if the CCA is intra- or extra-hepatic. Surgical removal of the tumor is the only potential cure, and CCA is very resistant to standard pharmaceutical drug treatment, though chemotherapy has some effect. Current chemotherapy uses cisplatin plus gemcitabine. Photochemical internalisation (PCI) is a novel technology, where photochemical reactions are used to enhance the effect of drugs by increasing their ability cross cell membranes to interact with their intended target. This study will assess the safety and effectiveness of fimaporfin-induced PCI of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable CCA. NOTE: Participants are no longer being recruited to this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04099888
Study type Interventional
Source PCI Biotech AS
Contact
Status Terminated
Phase Phase 2
Start date May 23, 2019
Completion date May 6, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05179486 - Molecular Epidemiology of Biliary Tree Cancers
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Terminated NCT04304781 - Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer Phase 1
Completed NCT03150615 - Enteral Nutrition After Pancreaticoduodenectomy N/A
Completed NCT01912053 - Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma Phase 2
Recruiting NCT01439698 - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry N/A
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT01206049 - Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations Phase 2
Recruiting NCT00973713 - Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Phase 2
Terminated NCT00975039 - Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma Phase 2
Completed NCT00779454 - Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Phase 2
Terminated NCT04066491 - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC Phase 2/Phase 3
Recruiting NCT04340986 - Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03603834 - Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2