Clinical trialPhase 3Active not recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 3
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 29 March 2023
- Expected end
- December 2027
- Enrollment
- 11 participants
- Sites
- 1
- Primary outcomes
- Rates of SignateraTM ctDNA positive Patient identification; Rate of Enrollment; Rate of ctDNA Complete Response (CR); Rate of ctDNA Partial Response (PR); Rate of ctDNA Progression of Disease (POD) or Clinical/radiographic Relapse
- Sponsor
- Other
- Results posted
- No
- Last update
- 6 October 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (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.