Actively Recruiting
Evaluating Novel Therapies in ctDNA Positive GI Cancers
Led by Georgetown University · Updated on 2025-05-22
20
Participants Needed
3
Research Sites
296 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Novel Therapies in ctDNA Positive GI Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at time of consent
- Able to follow the study protocol as judged by the investigator
- Histologically or cytologically confirmed colorectal, gastric, pancreatic, hepatocellular, biliary tract, or gallbladder adenocarcinoma
- Completed all curative-intent treatment for any stage disease, including surgery and perioperative therapies
- For hepatocellular carcinoma, must have Child Pugh A score at screening
- Completed all standard of care treatment with curative intent per local guidelines or clinical trial
- Patients treated definitively for oligometastatic disease with no evidence of disease are eligible
- No evidence of recurrent, residual, or metastatic disease on imaging within 28 days prior to enrollment
- Positive tumor-specific ctDNA SignateraTM test within 1 year of completing curative treatment and within 28 days prior to enrollment
- ECOG performance status 0 to 2
- Adequate blood counts and organ function within 28 days prior to treatment
- Stable anticoagulation if receiving therapeutic anticoagulants
- Negative HIV test or stable HIV infection with controlled viral load
- Select patients with well-compensated, treated HBV or chronic HCV infection
- Women of childbearing potential must have negative pregnancy test within 28 days prior to treatment
- Women must not be breastfeeding
- Women of childbearing potential agree to abstain or use effective contraception during and after treatment
- Men agree to abstain or use contraception during and after treatment
You will not qualify if you...
- Evidence or suspicion of residual, recurrent, or metastatic disease within 28 days before starting study treatment
- Have not received all recommended standard of care therapy without valid medical reason
- Active or history of autoimmune disease or immune deficiency, with some exceptions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease or vascular disease within specified recent timeframes
- Uncontrolled or severe hypertension
- History of severe blood clotting or bleeding disorders
- Recent use of high-dose aspirin or clopidogrel
- Chronic daily use of NSAIDs (occasional use allowed)
- Recent major surgery or significant injury within 28 days prior to treatment
- Recent local therapy to liver or other organs within 28 days prior to treatment
- Untreated or high-risk esophageal or gastric varices
- Recent bleeding from varices within 6 months
- Minor biopsy or surgery within 7 days prior to treatment
- Active infection requiring IV antibiotics or severe infection within 4 weeks prior
- Recent history of gastrointestinal bleeding or fistula
- Serious non-healing wounds or fractures
- Previous malignancies except certain low-risk cases with remission
- Prior stem cell or organ transplant
- Any other condition increasing risk or interfering with study
- Recent use of live vaccines
- Recent investigational therapy within 28 days prior to treatment
- Prior treatment with certain immune therapies
- Recent use of systemic immunostimulatory or immunosuppressive drugs with exceptions
- History of severe allergic reactions to study drugs or components
- Pregnancy, breastfeeding, or intent to become pregnant during or shortly after treatment
- Uncontrolled or symptomatic high calcium levels
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or fluid build-up requiring frequent drainage
- Untreated or progressing central nervous system metastases except stable treated lesions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
L
Loyanna Hubbard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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