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โ† Trials
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CapTemY90 for Grade 2/3 NET Liver Metastases

RecruitingPhase 2Ages 18 Years - anyAllAbramson Cancer Center at Penn Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ50% 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 โ‰ค 2.0mg/dl, ALT, AST โ‰ค5 times ULN, albumin โ‰ฅ2.5g/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 ฮฒHCG 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 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
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What it tests

  • Capecitabine Oral Product
  • Temozolomide Oral Product
  • transarterial radioembolization
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Where

5 sites
UC San Diego
La Jolla, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Miami, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
University of Pennsylvania
Philadelphia, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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