NCT04339036

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with liver-dominant Grade 2/3 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance. Primary outcome measure is hepatic progression-free survival.

Conditions

• Neuroendocrine Tumor Grade 2
• Neuroendocrine Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-07
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2020-04-08
• Last updated: 2025-12-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study