NCT04339036 CapTemY90 for Grade 2/3 NET Liver Metastases
| NCT ID | NCT04339036 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Neuroendocrine Tumor Grade 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-10-07 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2021-10-07 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michael Soulen
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT04339036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumor Grade 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04339036 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04339036 currently recruiting?
Yes, NCT04339036 is actively recruiting participants. Contact the research team at michael.soulen@pennmedicine.upenn.edu for enrollment information.
Where is the NCT04339036 trial being conducted?
This trial is being conducted at La Jolla, United States, Miami, United States, Buffalo, United States, Philadelphia, United States.
Who is sponsoring the NCT04339036 clinical trial?
NCT04339036 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Michael Soulen at University of Pennsylvania. The trial plans to enroll 70 participants.