| Study Name |
|
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer ( RELEASE ) |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT04099888 |
| Clinical Trial Category (check all that apply) |
|
- First Line Therapy
- Chemotherapy
- Targeted Therapy
|
| Study Center |
| Institution Name |
|
PCI Biotech |
| City |
|
Oslo |
| Country |
|
Norway |
| Study Contacts |
| Principal Investigator |
|
PCI Biotech AS |
| P.I. Phone |
|
(000) 000-0000 |
| P.I. Email |
|
ClinicalTrials@pcibiotech.com |
| Study Coordinator |
|
TBD |
| Study Coordinator Phone |
|
(000) 000-0000 |
| Study Coordinator Email |
|
ClinicalTrials@pcibiotech.com |
| OVERVIEW – in layman’s terms (150 words max) |
|
This study contains of 2 potential treatment arms, one including the experimental drug (Amphinex) and in addition to up to 8 cycles of; gemcitabine and cisplatin, the other arm includes only the gemcitabine and cisplatin. Even if you will not receive the experimental treatment you will receive what is considered standard of care for your disease. |
| Enrollment |
|
Yes |
| Study Start Date |
|
11/18/2019 |
| Estimated Completion Date |
|
04/30/2024 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
|
- The purpose of this study, which involves research, is to determine if a new treatment known as photochemical internalization (PCI treatment) will be an effective and safe treatment option for patients with inoperable CCA compared with the standard combination chemotherapy with gemcitabine and cisplatin.
|
| Inclusion Criteria – Patients Must: |
|
- Have cholangiocarcinoma (CCA) of which cannot be treated with surgery (inoperable)
- CCA in the perihilar and distal region
- Have a CCA that requires a stent in your bile duct
- CCA that has not metastasized (spread) to other regions than within the liver
|
| Exclusion Criteria – Patients Must NOT: |
|
- Have received any other cancer treatments for your CCA
|
| REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms |
|
- Biopsy or cytology sample to confirm that you have CCA
- Have your disease checked with imaging (either MRI or CT)
|
| POTENTIAL SIDE-EFFECTS – in layman’s terms |
|
- You may be light sensitive especially if going outdoors for a certain period after receiving Amphinex
- You may experience other known side effects of gemcitabine and cisplatin
|
