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Preoperative Radiotherapy and E7046 in Rectum Cancer
NCT03152370 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.
Conditions Studied
Interventions
- DRUG capecitabine
- DRUG E7046
- RADIATION Long Course Chemoradiotherapy (LCRT)
- RADIATION Short Course Radiotherapy (SCRT)
- DRUG folinic acid/5-FU/oxaliplatin (mFOLFOX-6)
Study Locations (5)
Other
- Marie-Skodowska Curie Cancer Centre — Warsaw
- The Christie — Manchester
- Mount Vernon Hospital — Northwood
Massachusetts
- Massachusetts General Hospital — Boston
New York
- Weill Cornell — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03152370
The ClinicalTrials.gov registry entry for NCT03152370 describes a study currently listed as completed. 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 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adlai Nortye Biopharma Co., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neoadjuvant Therapy in Rectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which capecitabine 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: NCT03152370 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Other, Massachusetts, New York. 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 NCT03152370 about?
NCT03152370 is a clinical study titled "Preoperative Radiotherapy and E7046 in Rectum Cancer". This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerabilit...
What is the current status of trial NCT03152370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-05-17. Estimated completion is 2021-09-30.
What conditions does trial NCT03152370 study?
This clinical trial studies the following conditions: Neoadjuvant Therapy in Rectal 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 NCT03152370?
The interventions under investigation include: capecitabine (DRUG), E7046 (DRUG), Long Course Chemoradiotherapy (LCRT) (RADIATION), Short Course Radiotherapy (SCRT) (RADIATION), folinic acid/5-FU/oxaliplatin (mFOLFOX-6) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03152370?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03152370 being conducted?
This trial has 5 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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