RecruitingPhase 3NCT05482516

Evaluating Novel Therapies in ctDNA Positive GI Cancers

Evaluating Novel Therapies and ctDNA as a Marker in Curatively-Treated Gastrointestinal Cancers With Microscopic Residual Disease


Sponsor

Georgetown University

Enrollment

20 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new therapies for people with gastrointestinal (GI) cancers — including colorectal, stomach, pancreatic, liver, and bile duct cancers — whose doctors believe the cancer has been completely treated with curative intent but who are at high risk of relapse based on circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA detectable in the blood. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colorectal, gastric, pancreatic, hepatocellular, or bile duct adenocarcinoma - Your cancer was treated with the goal of cure (surgery plus any recommended chemotherapy, radiation, etc.) - Your ctDNA blood test is positive after completing treatment, suggesting cancer may still be present - If you have liver cancer (HCC), your liver function score must be Child-Pugh A **You may NOT be eligible if...** - Your cancer was not treated with curative intent - Your ctDNA is negative - You have not completed all recommended standard treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway,

DRUGBevacizumab

Bevacizumab is a tumor-starving (anti-angiogenic) therapy. Avastin is designed to block a protein called vascular endothelial growth factor, or VEGF.


Locations(3)

Georgetown Lombardi Comprehensive Cancer Center

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

Medstar Washington Hospital Center

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

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT05482516


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