RecruitingPhase 2NCT04339036

CapTemY90 for Grade 2/3 NET Liver Metastases

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

70 participants

Start Date

Oct 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a triple-therapy approach for people with neuroendocrine tumors (slow-growing cancers that often start in the gut or pancreas) that have spread to the liver and cannot be removed by surgery. The combination includes two oral chemotherapy drugs (capecitabine and temozolomide) and a liver-targeted radiation therapy called Y-90 radioembolization, which delivers radiation directly to liver tumors via tiny beads. **You may be eligible if...** - You are 18 years or older - You have a confirmed grade 2 or 3 well-differentiated neuroendocrine tumor with liver metastases that cannot be surgically removed - At least half of your total cancer burden is in the liver - You have at least one liver tumor larger than 1 cm - Your liver tumor burden does not exceed 50% of total liver volume - Your liver, blood, and kidney function meet minimum requirements - You have a life expectancy greater than 6 months **You may NOT be eligible if...** - You have previously had liver embolization or Y-90 radioembolization - You are allergic to capecitabine or temozolomide - You cannot have both MRI and CT scans - You are pregnant Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCapecitabine Oral Product

Capecitabine 750 mg/m2 twice daily orally for 14 days

DRUGTemozolomide Oral Product

temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles

COMBINATION_PRODUCTtransarterial radioembolization

Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.


Locations(4)

UC San Diego

La Jolla, California, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04339036


Related Trials