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New treatment option for Neuroendocrine Tumor Grade 2
Official title CapTemY90 for Grade 2/3 NET Liver Metastases
ClinicalTrials.gov ID: NCT04339036
What this study is testing
What is Capecitabine Oral Product?
Capecitabine Oral Product is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neuroendocrine tumor grade 2.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary...
- 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
You likely can't join 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
See the full eligibility 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)
- 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
- people 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...
- Pregnant and lactating women are ineligible
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Miami, Florida, United States
- Buffalo, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Miami, Florida, United States; Buffalo, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.