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CapTemY90 for Grade 2/3 NET Liver Metastases

NCT04339036 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Michael Soulen · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2026-05-01
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339036 on ClinicalTrials.gov