Tests capecitabine, temozolomide and radioembolization for liver-spread neuroendocrine tumors
Tests combined drug and radiation treatment in adults with liver-spread neuroendocrine tumors.
Plain-language title generated from the registry record
Registry title: CapTemY90 for Grade 2/3 NET Liver Metastases
Key facts
- Where
- Buffalo, La Jolla, Miami, and Philadelphia, United StatesSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with well differentiated grade 2 or 3 neuroendocrine tumor that has spread to the liver and cannot be removed by surgery. The treatment is capecitabine and temozolomide together with Y90 radioembolization.
- Age
- Over 18 years.
- Sex
- All sexes can join.
- Disease stage
- Well differentiated grade 2 or 3 neuroendocrine tumor with liver metastases that cannot be removed by surgery. At least one liver metastasis larger than 1cm (0.4 in). At least 50% of the tumor is in the liver, and the tumor takes up no more than 50% of the liver volume. Open main portal vein.
- Earlier treatment
- At least 4 weeks since the last chemotherapy or radiotherapy. No earlier transarterial embolization or radioembolization (Y-90 microspheres).
Main reasons for not taking part
- Cannot take capecitabine or temozolomide
- Cannot have both contrast-enhanced MRI and CT
- Cannot have radioembolization, for example a large shunt from liver to lung
- Taking any other investigational drug
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in United States
- Roswell Park Comprehensive Cancer CenterBuffalo, United StatesNo longer taking part
- UC San DiegoLa Jolla, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at PlantationMiami, United StatesNo longer taking part
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abramson Cancer Center at Penn Medicine
- Trial code
- NCT04339036
- Record updated
- 8 October 2026
- Original 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.Read full original descriptionShow less
UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors
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.
Inclusion: 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: Contraindications to capecitibine or temozolomide; Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres); Patients may not be receiving any other investigational agents; Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication); Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; Contraindicated for both contrast-enhanced MRI and CT; Contraindication for radioembolization procedures:; excessive hepatopulmonary shunt as determined by the investigator; inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures; Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced; Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla; Pregnant and lactating women are ineligible.