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RECRUITING Phase 3

Evaluating Novel Therapies in ctDNA Positive GI Cancers

NCT05482516 · View on ClinicalTrials.gov ↗

Study Summary

This study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall bladder adenocarcinomas) diagnosed with histologically confirmed GI cancers. These patients will have already completed all Standard of Care (SOC) treatments (including neoadjuvant, surgery, local therapies, and/or adjuvant therapy as applicable), as defined by the treating primary physician or research team, with curative intent but have a positive SignateraTM tumor-informed ctDNA test and NED radiographically by standard imaging within 28 days prior to enrollment and within 1 year of completing all curative-intent therapy. All patients will be treated with intravenous (IV) atezolizumab 1200 mg IV and bevacizumab 15 mg/kg on Day 1 of 21-day cycles until disease recurrence, ctDNA POD, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month total duration of study therapy. Atezolizumab and bevacizumab drug will be provided.

Interventions

  • DRUG Bevacizumab
  • DRUG Atezolizumab

Study Locations (3)

District of Columbia

  • Georgetown Lombardi Comprehensive Cancer Center — Washington D.C.
  • Medstar Washington Hospital Center — Washington D.C.

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-03-29
Est. Completion 2028-12
Phase Phase 3

Sponsor

Georgetown University

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05482516

The ClinicalTrials.gov registry entry for NCT05482516 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Bevacizumab 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: NCT05482516 reports 3 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, New Jersey. 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 NCT05482516 about?

NCT05482516 is a clinical study titled "Evaluating Novel Therapies in ctDNA Positive GI Cancers". This study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall bladder adenocarcinomas) diagnosed with histologically confirmed GI cancers. ...

What is the current status of trial NCT05482516?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2023-03-29. Estimated completion is 2028-12.

What conditions does trial NCT05482516 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Rectal Adenocarcinoma, Colon Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05482516?

The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05482516?

This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05482516 being conducted?

This trial has 3 study locations across District of Columbia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial