CapTemY90 for Grade 2/3 NET Liver Metastases

NCT04339036 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: UPCC 0421904219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Intra-hepatic progression-free survival

  Intra-hepatic progression-free survival by RECIST 1.0 is defined as the 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.

  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.

Secondary Outcomes (8)

• Overall Progression free survival

  2 years. time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status

• Intra-hepatic tumor responses by RECIST

  2 years. from time of initiation of study therapy until subject comes off of study, or study closes

• Intra-hepatic tumor responses by EASL

  2 years. from time of initiation of study therapy until subject comes off of study, or study closes

• extra-hepatic tumor responses

  2 years. from time of initiation of study therapy until subject comes off of study, or study closes

• Number of participants with systemic toxicities

  From period of enrollment to 24 months after last treatment

Study Arms (1)

Oral CapTem + Y90 Radioembolization

EXPERIMENTAL

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.

Drug: Capecitabine Oral Product; Drug: Temozolomide Oral Product; Combination Product: transarterial radioembolization

Interventions

Capecitabine Oral Product DRUG

Capecitabine 750 mg/m2 twice daily orally for 14 days

Also known as: Xeloda

Oral CapTem + Y90 Radioembolization

Temozolomide Oral Product DRUG

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

Also known as: Temodar

Oral CapTem + Y90 Radioembolization

transarterial radioembolization COMBINATION_PRODUCT

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.

Also known as: TARE, y90

Oral CapTem + Y90 Radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (4)

UC San Diego

La Jolla, California, 92037, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

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MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Capecitabine; Temozolomide; Yttrium-90

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Michael Soulen

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Soulen, MD

CONTACT

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

Veronica Faris

CONTACT

Veronica.Faris@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 8, 2020
• Study Start: October 7, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)