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Clinical trialNCT05482516RecruitingPhase 3Interventional

Evaluating Novel Therapies in ctDNA Positive GI Cancers

SponsorGeorgetown UniversityEnrollment20Adenocarcinoma of Biliary TractColon AdenocarcinomaGallbladder AdenocarcinomaGastric AdenocarcinomaHepatocellular CarcinomaPancreatic Adenocarcinoma+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, United States

    John L. Marshall, MD
    Recruiting
  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, United States

    Marcus Noel, MD
    Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, United States

    Martin Gutierrez, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Mar 2023
Primary completion
31 Dec 2026
Completion
31 Dec 2028
Last update posted
22 May 2025
Registered enrollment
20
Registry id
NCT05482516

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.