RECRUITING

CapTemY90 for Grade 2/3 NET Liver Metastases

Conditions

Neuroendocrine Tumor Grade 2 Neuroendocrine Tumors

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. A Grade 3 arm was added in 2025.

Official Title

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors

Quick Facts

Study Start:2021-10-07

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04339036

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 ≥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

Inclusion Criteria

Exclusion 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 ≥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

Contacts and Locations

Study Contact

Michael Soulen, MD

CONTACT

855-216-0098

michael.soulen@pennmedicine.upenn.edu

Veronica Faris

CONTACT

Veronica.Faris@pennmedicine.upenn.edu

Principal Investigator

Michael Soulen

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

UC San Diego

La Jolla, California, 92037

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19103

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Michael Soulen, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-07

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2021-10-07

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Neuroendocrine Tumor Grade 2
Neuroendocrine Tumors