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CapTemY90 for Grade 2/3 Neuroendocrine Tumor Liver Metastases

This study is testing a combination of treatments for people with Grade 2 or 3 neuroendocrine tumors (NETs) that have spread to the liver and cannot be removed by surgery. The treatments include two oral medications, Capecitabine and Temozolomide (often called CapTem), along with transarterial radioembolization (TARE), which is a procedure that delivers radiation directly to the liver tumors. Researchers want to see if this combination is safe and if it helps control the disease in the liver better than either treatment alone. You might be able to join if you have a confirmed diagnosis of Grade 2 or 3 NETs with liver metastases, and at least one liver tumor is larger than 1cm. The main goal is to see how long people live without their disease getting worse in the liver, measured over two years. The current status of this study is unclear.

Study design
This is a Phase 2 interventional study aiming to enroll 70 participants. It is evaluating the combination of CapTem and Y90 radioembolization for liver-dominant NET metastases.
What's involved
You would start taking Capecitabine and Temozolomide. During the first cycle, you would have a simulation angiography for radioembolization planning. If you tolerate the medications, TARE would be performed on Day 7 of Cycle 2, with additional TARE as needed. You would continue CapTem until your disease progresses or you can no longer tolerate it.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, intra-hepatic progression-free survival, is measured at 2 years after starting study therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04339036

CapTemY90 for Grade 2/3 NET Liver Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~70 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Capecitabine Oral ProductTemozolomide Oral Producttransarterial radioembolization

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-hepatic progression-free survival
Measured over 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.

Conditions

Neuroendocrine Tumor Grade 2
Neuroendocrine Tumors

Explore related trials

Neuroendocrine Tumor

Where it's being run

4 sites across 4 states
California1
Florida1
New York1
Pennsylvania1

Study leadership

  • Michael Soulen · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Michael Soulen, MD
[email protected]
855-216-0098
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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
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

What this trial measures

  • Intra-hepatic progression-free survival2 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.