Actively Recruiting
CapTemY90 for Grade 2/3 NET Liver Metastases
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-12-10
70
Participants Needed
4
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CapTemY90 for Grade 2/3 NET Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases
- At least one measurable liver metastasis larger than 1 cm
- Liver-dominant disease with 50% or more tumor burden in the liver
- Liver tumor burden does not exceed 50% of liver volume
- Patent main portal vein
- At least 4 weeks since last chemotherapy or radiotherapy
- Age 18 years or older
- Life expectancy greater than 6 months
- ECOG performance status between 0 and 2
- Adequate liver function: Total bilirubin ≤ 2.0 mg/dl, ALT and AST ≤ 5 times upper limit of normal, albumin ≥ 2.5 g/dl
- Adequate organ and marrow function: platelets > 100,000/mcL, serum creatinine < 2.0 mg/dl, INR < 1.6
- Ability to understand and sign informed consent
- Use of effective contraception for women of childbearing potential and fertile men, with negative pregnancy test for eligible women
You will not qualify if you...
- Contraindications to Capecitabine or Temozolomide
- Contraindications for contrast-enhanced MRI and CT
- Prior treatment with transarterial embolization or radioembolization (Y-90 microspheres)
- Contraindications for radioembolization including excessive hepatopulmonary shunt or risk of non-target embolization
- Failure of simulation angiography after consenting to trial
- Receiving other investigational agents
- Absolute contraindication to intravenous iodinated contrast
- Presence of choledochoenteric anastomosis, transpapillary stent, or sphincterotomy of duodenal papilla
- Uncontrolled illnesses such as active infection, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UC San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
Research Team
M
Michael Soulen, MD
CONTACT
V
Veronica Faris
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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