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RECRUITING
NCT04339036
PHASE2

CapTemY90 for Grade 2/3 NET Liver Metastases

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-10-07

Completion Date

2026-05-01

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DRUG

Capecitabine Oral Product

Capecitabine 750 mg/m2 twice daily orally for 14 days

DRUG

Temozolomide Oral Product

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

COMBINATION_PRODUCT

transarterial 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