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NCT07146646 · ClinicalTrials.gov registry record · Phase 2
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer
A Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT07146646: Recruiting Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, sponsored by Case Comprehensive Cancer Center.
NCT07146646 is a Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07146646, a Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).
Primary Outcome
DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or SD, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increas
Conditions Studied
Interventions
- DRUG Oxaliplatin
- DRUG Trifluridine/tipiracil
Study Locations (2)
Ohio
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What NCT07146646 shows while recruiting
NCT07146646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT07146646 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07146646 about?
NCT07146646 is a clinical study titled "Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer". Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combinat...
What is the current status of trial NCT07146646?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2025-12-01. Estimated completion is 2027-04.
What conditions does trial NCT07146646 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Biliary Tract Cancer, Gallbladder Cancer, Biliary Tract Neoplasms, Gallbladder Carcinoma.
What interventions are being tested in trial NCT07146646?
The interventions under investigation include: Oxaliplatin (DRUG), Trifluridine/tipiracil (DRUG).
Who is sponsoring clinical trial NCT07146646?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07146646 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07146646's enrollment target sits among peer trials
27 53rd of 60 higher than 8 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma 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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