CapTemY90 for Grade 2/3 NET Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.
A Grade 3 arm was added in 2025.
Eligibility criteria
Qualifiers
Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)
Patients with at least one measurable liver metastases, with size > 1cm (RECIST criteria)
Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
Liver tumor burden does not exceed 50% of the liver volume
Disqualifiers
Contraindications to capecitibine or temozolomide
Contraindicated for both contrast-enhanced MRI and CT
Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)
excessive hepatopulmonary shunt as determined by the investigator
Trial design
Treatments tested in this trial
- Capecitabine Oral Product
- Temozolomide Oral Product
- transarterial radioembolization
Treatment groups
70 Participants
are divided into 1 treatment groupLocations
4UC San Diego92037, La JollaCalifornia, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center33136, MiamiFlorida, United States
Roswell Park Comprehensive Cancer Center14203, BuffaloNew York, United States
University of Pennsylvania19103, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
Source ClinicalTrials.gov