CapTemY90 for Grade 2/3 NET Liver Metastases (NCT04339036) | Clinical Trial Compass
RecruitingPhase 2
CapTemY90 for Grade 2/3 NET Liver Metastases
United States70 participantsStarted 2021-10-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Ability to understand and the willingness to sign a written informed consent document.
* Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intra-hepatic progression-free survival
Timeframe: 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.