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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Capecitabine Oral Product
DrugCapecitabine 750 mg/m2 twice daily orally for 14 days
Temozolomide Oral Product
Drugtemozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
transarterial radioembolization
Combination productTrans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Oral CapTem + Y90 RadioembolizationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Intra-hepatic progression-free survival
Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.
Time frame
2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.Secondary outcomes
1
Overall Progression free survival
Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status
Time frame
2 years. time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status2
Intra-hepatic tumor responses by RECIST
Intra-hepatic tumor responses will be evaluated by RECIST.
Time frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closes3
Intra-hepatic tumor responses by EASL
Intra-hepatic tumor responses will be evaluated by EASL criteria.
Time frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closes4
extra-hepatic tumor responses
extra-hepatic tumor responses will be evaluated by RECIST.
Time frame
2 years. from time of initiation of study therapy until subject comes off of study, or study closesSponsors and contacts
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Source ClinicalTrials.gov