CapTemY90 for Grade 2/3 NET Liver Metastases

Recruiting now · Phase 2

Conditions studied: Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors

In brief

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.

Key facts

Study ID: NCT04339036
Run by: Abramson Cancer Center at Penn Medicine
People needed: 70
Starts: 2021-10-07
Expected to finish: 2028-07-01
Last updated by the study team: 2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 microspheres)
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.
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).
Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;
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.
Pregnant and lactating women are ineligible

Where it is running

UC San Diego — La Jolla, California, United States (enrolling)
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.