Recruiting

Phase 2

CapTemY90CapTemY90 for Grade 2/3 NET Liver Metastases

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT04339036

Conditions

Neuroendocrine Tumor Grade 2

Neuroendocrine Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Capecitabine Oral Product

Temozolomide Oral Product

transarterial radioembolization

Study Details

Brief 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

Neuroendocrine Tumor Grade 2

Neuroendocrine Tumors

Study ID

NCT04339036

Start date

Oct 7, 2021

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral CapTem + Y90 Radioembolization

Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities.

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.

Interventions

Capecitabine Oral Product

Capecitabine 750 mg/m2 twice daily orally for 14 days

Temozolomide Oral Product

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

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.

Primary outcome measure

Intra-hepatic progression-free survival [ Time Frame: 2 years. Time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status. ]

Central Contacts and Locations

Central contacts

Michael Soulen, MD

855-216-0098 michael.soulen@pennmedicine.upenn.edu

Veronica Faris

Veronica.Faris@pennmedicine.upenn.edu

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Osita Ofuani, BS

oofuani@health.ucsd.edu

Michaela Doering, BS

mdoering@health.ucsd.edu

Principal Investigator:

Zachary Berman, md

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Lindsay Thornton, MD

305-243-5509 lxt404@miami.edu

Principal Investigator:

Lindsay Thornton, MD

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Contacts

Deepon Paul Singh

1-800-767-9355 mailto:askroswell@roswellpark.org

Principal Investigator:

Renuka Iyer, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Contacts

Abashai Woodard

215-746-7050 abashai.woodard@pennmedicine.upenn.edu

Principal Investigator:

Michael Soulen, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-04.