Status:
RECRUITING
CapTemY90 for Grade 2/3 NET Liver Metastases
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Neuroendocrine Tumor Grade 2
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hyp...
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 CapT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04339036
Start Date
October 7 2021
End Date
May 1 2026
Last Update
December 10 2025
Active Locations (4)
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1
UC San Diego
La Jolla, California, United States, 92037
2
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
3
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103