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TAS102 in Combination With NAL-IRI in Advanced GI Cancers
NCT03368963 · View on ClinicalTrials.gov ↗
Study Summary
This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Conditions Studied
Interventions
- DRUG Trifluridine and Tipiracil Hydrochloride
- DRUG Nanoliposomal Irinotecan
Study Locations (3)
Georgia
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
- Emory Saint Joseph's Hospital — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2025-11-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03368963
The ClinicalTrials.gov registry entry for NCT03368963 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions — of which Trifluridine and Tipiracil Hydrochloride is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03368963 reports 3 study locations spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03368963 about?
NCT03368963 is a clinical study titled "TAS102 in Combination With NAL-IRI in Advanced GI Cancers". This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by sur...
What is the current status of trial NCT03368963?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-01-30. Estimated completion is 2025-11-28.
What conditions does trial NCT03368963 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma, Stage IV Pancreatic Cancer, Stage IV Gastric Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03368963?
The interventions under investigation include: Trifluridine and Tipiracil Hydrochloride (DRUG), Nanoliposomal Irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03368963?
This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03368963 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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