drugset / Trial / NCT04099888
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-05-23
- Primary completion
- 2022-04-28
- Completion
- 2022-05-06
Outcome
Outcome not reported
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.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fimaporfin | Other / unclassified | 0.22 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |