A Phase 2 interventional study of Capecitabine Oral Product and Temozolomide Oral Product in Neuroendocrine Tumor Grade 2 and Neuroendocrine Tumors, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Treatment
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.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 70 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities. 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.
Drug: Capecitabine Oral Product · Drug: Temozolomide Oral Product · Combination Product: transarterial radioembolization
Capecitabine 750 mg/m2 twice daily orally for 14 days
Also known as: Xeloda
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
Also known as: Temodar
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.
Also known as: TARE, y90
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
Number 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 .
Plan to share: No
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Abramson Cancer Center at Penn Medicine