NCT04339036 · Abramson Cancer Center at Penn Medicine
CapTemY90 for Grade 2/3 NET Liver Metastases
(CapTemY90)
What this study is about
This is a Phase 2 evaluation of hepatic-time without the disease getting worse among patients with Grade 2 liver-dominant NET metastases undergoing two or more treatments used together 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.
View original scientific description
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.
Interventions
DRUG
Capecitabine Oral Product
Capecitabine 750 mg/m2 twice daily orally for 14 days
DRUG
Temozolomide Oral Product
temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
COMBINATION_PRODUCT
transarterial radioembolization
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.
Primary outcome measures
Intra-hepatic progression-free survival
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Patent main portal vein
- At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
- Age \>18 years.
- Life expectancy of greater than 6 months.
- ECOG performance status 0-2.
- Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl.
- Patients must have adequate organ and marrow function as defined below:
- platelets \>100,000/mcL (may be corrected by transfusion)
- serum creatinine \< 2.0 mg/dl
- INR \<1.6, (may be corrected by transfusion)
Where
- La Jolla, California
- Miami, Florida
- Buffalo, New York
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations