Study on CapTem and Y90 Radioembolization for Grade 2 Neuroendocrine Tumor Liver Metastases

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04339036

Provider View

This clinical trial is testing a combination of CapTem chemotherapy and Y90 radioembolization to see if it can better control liver metastases in patients with Grade 2 neuroendocrine tumors compared to using either treatment alone.

Patient Parameters

Program Overview

The study aims to evaluate if combining CapTem chemotherapy with Y90 radioembolization can improve the control of liver metastases in patients with Grade 2 neuroendocrine tumors. Researchers want to confirm the safety of this combination and see if it offers better disease control than using each treatment separately.

Description

Patients with Grade 2 neuroendocrine tumors that have spread to the liver will start treatment with CapTem chemotherapy. During the first cycle, they will also undergo a planning procedure for Y90 radioembolization. If they tolerate CapTem and are eligible for radioembolization, the Y90 treatment will be given on Day 7 of the second cycle, with additional treatments in later cycles if needed to target all liver tumors. Patients will continue taking CapTem until the cancer progresses or they can no longer tolerate the treatment.

The main goal is to measure how long patients can go without their liver tumors getting worse.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Grade 2 neuroendocrine tumor with liver metastases that cannot be surgically removed.
  • Have at least one liver tumor that is larger than 1 cm.
  • The majority of the cancer is in the liver, with at least 50% of the tumor burden in the liver.
  • Liver tumors do not take up more than 50% of the liver's volume.
  • Have a clear main portal vein.
  • At least 4 weeks since the last chemotherapy or radiotherapy.
  • Be over 18 years old.
  • Have a life expectancy of more than 6 months.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate liver function and organ health as shown by specific blood tests.
  • Be able to understand and sign a consent form.
  • Women of childbearing age and men must use effective birth control.

Exclusion Criteria

  • Cannot take capecitabine or temozolomide.
  • Cannot have both MRI and CT scans with contrast.
  • Have had previous treatments like transarterial embolization or radioembolization.
  • Have conditions that make radioembolization unsafe, such as excessive blood flow between the liver and lungs or risk of affecting other organs.
  • Cannot participate if they fail the planning procedure for radioembolization.
  • Cannot be taking other experimental treatments.
  • Have a severe allergy to contrast used in scans that cannot be managed with medication.
  • Have certain medical conditions like a bile duct surgery or stent, or severe illness that would interfere with the study.
  • Pregnant or breastfeeding women cannot participate.

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