Clinical trial · Interventional
CapTemY90 for Grade 2/3 NET Liver Metastases
UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine Oral Product | Drug | — | UNRESOLVED |
| Temozolomide Oral Product | Drug | — | UNRESOLVED |
| transarterial radioembolization | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral CapTem + Y90 Radioembolization
- description
- 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.
- interventionNames
- Drug: Capecitabine Oral Product
- Drug: Temozolomide Oral Product
- Combination Product: transarterial radioembolization
Primary outcomes (1)
- measure
- Intra-hepatic progression-free survival
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (24)
- BACKGROUNDModlin IM, Moss SF, Chung DC, Jensen RT, Snyderwine E. Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008 Sep 17;100(18):1282-9. doi: 10.1093/jnci/djn275. Epub 2008 Sep 9. PMID 18780869
- BACKGROUNDNorheim I, Oberg K, Theodorsson-Norheim E, Lindgren PG, Lundqvist G, Magnusson A, Wide L, Wilander E. Malignant carcinoid tumors. An analysis of 103 patients with regard to tumor localization, hormone production, and survival. Ann Surg. 1987 Aug;206(2):115-25. doi: 10.1097/00000658-198708000-00001. PMID 2440390
- BACKGROUNDTalamonti MS, Stuart K, Yao JC. Neuroendocrine tumors of the gastrointestinal tract: how aggressive should we be? In: Perry M, ed. American Society of Clinical Oncology 2004 Education Book. Alexandria: American Society of Clinical Oncology, 2004;206-215.
- BACKGROUNDArnold R, Trautmann ME, Creutzfeldt W, Benning R, Benning M, Neuhaus C, Jurgensen R, Stein K, Schafer H, Bruns C, Dennler HJ. Somatostatin analogue octreotide and inhibition of tumour growth in metastatic endocrine gastroenteropancreatic tumours. Gut. 1996 Mar;38(3):430-8. doi: 10.1136/gut.38.3.430. PMID 8675099
- BACKGROUNDSaltz L, Trochanowski B, Buckley M, Heffernan B, Niedzwiecki D, Tao Y, Kelsen D. Octreotide as an antineoplastic agent in the treatment of functional and nonfunctional neuroendocrine tumors. Cancer. 1993 Jul 1;72(1):244-8. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-q. PMID 8389666
- BACKGROUNDRinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24. PMID 19704057