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.
Patients with liver-dominant Grade 2/3 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance. Primary outcome measure is hepatic progression-free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Capecitabine 750 mg/m2 twice daily orally for 14 days
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
UC San Diego
La Jolla, California, United States
RECRUITINGUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
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.
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 status
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 closes
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 closes
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 closes
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGNumber of participants with systemic toxicities
Systemic toxicities will be individually assessed by NCI CTCAE Version 4.
Time frame: From period of enrollment to 24 months after last treatment
Number of participants with hepatic toxicities
Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.
Time frame: From period of enrollment to 24 months after last treatment
Change in CgA over time
The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.
Time frame: Tumor markers will be assessed at baseline and then every 3 months for 24 months.
Quality of Life by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Neuroendocrine tumor
Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning
Time frame: Quality of life will be measured at baseline and then every 3 months for 24 months .