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NCT05482516 · ClinicalTrials.gov registry record · Phase 3
Evaluating Novel Therapies in ctDNA Positive GI Cancers
A Phase 3 study of Hepatocellular Carcinoma and Pancreatic Adenocarcinoma, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT05482516: Recruiting Phase 3 study of Hepatocellular Carcinoma and Pancreatic Adenocarcinoma, sponsored by Georgetown University.
NCT05482516 is a Phase 3 study of Hepatocellular Carcinoma and Pancreatic Adenocarcinoma that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 20 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05482516, a Phase 3 study of Hepatocellular Carcinoma and Pancreatic Adenocarcinoma, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
The number of local and regional SignateraTM ctDNA positive patients identified over 12 months in the setting of NED after all SOC definitive therapies (identified patients). This data will be obtained on a local and regional level through the SignateraTM company, Natera.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What NCT05482516 shows while recruiting
NCT05482516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (92% lower).
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.
NCT05482516 reports a single indexed study location in District of Columbia, New Jersey.
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.
What interventions are being tested in trial NCT05482516?
The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT05482516?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05482516's enrollment target sits among peer trials
20 123rd of 145 higher than 16 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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