Evaluating Novel Therapies in ctDNA Positive GI Cancers
Status:
Not yet recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
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.