Actively Recruiting
Evaluating Novel Therapies and ctDNA as a Marker in Curatively-Treated Gastrointestinal Cancers With Microscopic Residual Disease
Led by Georgetown University · Updated on 2025-05-22
20
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for gastrointestinal (GI) cancers in patients who have completed all standard curative therapies but still show microscopic residual disease. This is a non-randomized, open-label, multi-cohort pilot trial enrolling 20 patients with colorectal, gastric, pancreatic, hepatocellular, intra- or extra-hepatic biliary tract, and gallbladder adenocarcinomas confirmed by tissue testing. The goal is to study patients who have positive SignateraTM tumor-informed ctDNA tests despite no visible disease on imaging, to explore the effects of the investigational combination therapy in this setting. Participants will receive intravenous infusions of atezolizumab 1200 mg and bevacizumab 15 mg/kg on Day 1 of each 21-day cycle, repeated every three weeks for up to 12 months or until disease recurrence, ctDNA progression, unacceptable side effects, or withdrawal. This combination is designed to target cancer pathways and blood vessel growth. Treatments will continue under medical supervision with study drugs provided to participants. No placebo groups are used in this study. Throughout the study, patients will be closely monitored with physical exams, imaging scans, and blood tests including ctDNA assessments to measure cancer markers and treatment responses at specified intervals. Safety will be assessed by tracking side effects using established criteria. Researchers will also record enrollment rates and reasons for any enrollment failures. Participants will be followed for up to one year, with ongoing evaluations to assess treatment impact and disease progression.
CONDITIONS
Brief 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
- Ability to follow study protocol as judged by investigator
- Confirmed colorectal, gastric, pancreatic, hepatocellular, or biliary/gallbladder adenocarcinoma
- Completed all curative-intent treatments per physician judgment
- Hepatocellular carcinoma patients must have Child Pugh A score
- Completion of standard of care treatments including surgery and therapies
- Acceptable disease-free status confirmed by physical exam and imaging within 28 days
- Positive tumor-specific SignateraTM ctDNA test within 1 year of curative treatment and 28 days before enrollment
- ECOG performance status between 0 and 2
- Adequate blood counts and organ function within 28 days prior to treatment
- Stable anticoagulant regimen if applicable
- Negative HIV test or stable HIV on therapy with adequate CD4 and viral load
- Selected well-compensated HBV or treated HCV infections
- Women of childbearing potential must have negative pregnancy test and agree to contraceptive measures
- Women must not be breastfeeding
- Men must agree to contraceptive measures and abstain from sperm donation during and after treatment
You will not qualify if you...
- Evidence of gross residual, recurrent, or metastatic disease within 28 days before treatment
- Incomplete guideline-recommended standard treatments without valid medical reason
- Active or history of autoimmune or immune deficiency diseases with exceptions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular or vascular diseases within specified timeframes
- Uncontrolled hypertension or hypertensive crises
- History of severe venous thromboembolism or bleeding disorders
- Recent use of high-dose aspirin or clopidogrel
- Chronic daily NSAID use excluding occasional use
- Recent major surgery or trauma within 28 days
- Recent local liver or organ therapies within 28 days
- Untreated or high-risk esophageal/gastric varices
- Recent bleeding events or coagulopathy risks
- Active infections requiring IV antibiotics or severe recent infections
- History of severe allergic reactions to similar drugs
- Pregnancy, breastfeeding, or intention to become pregnant
- Uncontrolled hypercalcemia or tumor-related pain
- Active or progressing CNS metastases requiring treatment
- History of previous malignancies except certain exceptions
- Prior stem cell or organ transplants
- Use of immunostimulatory or immunosuppressive therapies within specific timeframes
- Treatment with certain investigational or immune checkpoint drugs
- Any other condition that may increase risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive atezolizumab and bevacizumab intravenously every 3 weeks as part of the treatment.
Approximately 17 infusions every 3 weeks
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
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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