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NCT06178588 · ClinicalTrials.gov registry record · Phase 2
Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma
A Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06178588: Active Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by University of Kansas Medical Center.
NCT06178588 is a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 15 participants, below the 41-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06178588, a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a toxic agent, called SN-38. HRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them.
Primary Outcome
Defined as best response recorded from the start of the treatment until the end of treatment (taking into account any requirement for confirmation). Measured by computed tomography (CT) (magnetic resonance imaging \[MRI\] if CT contraindicated) Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Will be reported as a proportion with corresponding 90% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
Study Locations (1)
Kansas
- University of Kansas Cancer Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 2 |
What the registry record for NCT06178588 still lists
NCT06178588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 41-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (63% lower).
The record links to 7 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06178588 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06178588 about?
NCT06178588 is a clinical study titled "Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma". This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) t...
What is the current status of trial NCT06178588?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-02-01. Estimated completion is 2026-11-01.
What conditions does trial NCT06178588 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Metastatic Cholangiocarcinoma, Recurrent Cholangiocarcinoma, Locally Advanced Cholangiocarcinoma.
What interventions are being tested in trial NCT06178588?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT06178588?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06178588 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06178588's enrollment target sits among peer trials
15 7th of 8 higher than 2 of 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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