CapTemY90 for Grade 2 NET Liver Metastases

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.

Conditions

Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors

Study Overview

Study Details

Study overview

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.

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

CapTemY90 for Grade 2 NET Liver Metastases

Condition
Neuroendocrine Tumor Grade 2
Intervention / Treatment

-

Contacts and Locations

La Jolla

UC San Diego, La Jolla, California, United States, 92037

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14203

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with confirmed diagnosis of histologic grade 2 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abramson Cancer Center at Penn Medicine,

Michael Soulen, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2026-05-01