TerminatedPhase 2

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

Stopped: Recent results from a Phase 3 study are expected to change the standard of care for patients with inoperable CCA, rendering the RELEASE study challenging to complete and potentially inadequate for NDA approval.

United States41 participantsStarted 2019-05-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Each patient must provide signed and witnessed written informed consent and agree to comply with study protocol requirements.
✓. Histopathologically/cytologically verified adenocarcinoma consistent with cholangiocarcinoma (CCA). Must have biliary lesion causing bile obstruction that requires stenting and is accessible for PCI light treatment (ie, extrahepatic CCA \[perihilar or distal\] only).
✓. CCA must be considered inoperable with respect to radical resection.
✓. At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation.
✓. If metastatic, metastases must be limited tissues other than bone or the central nervous system.
✓. Must have adequate biliary drainage (at least 50% of the liver volume or at least 2 sectors) with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
✓. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Estimated life expectancy of at least 12 weeks.

Exclusion criteria

What they're measuring

Progression-free Survival (PFS)

Timeframe: Up to 18 months

Trial details

NCT IDNCT04099888

SponsorPCI Biotech AS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-28

Results submitted2022-10-26

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