Clinical trial · Interventional
Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
NCT02512692CI-TRIAL-00082643terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment closed by internal scientific review committee due to slow accrual.
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| SIR-Spheres microspheres (Yttrium-90 Microspheres) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 90Y TARE with Gemcitabine and Cisplatin
- description
- 90Y TARE will be given on day 3 or 4 of cycle 1 and start at 75% of the dose calculated by the body surface area formula and escalated by 25% per cohort in combination with cisplatin 25 mg/m2 and gemcitabine 300 mg/m2 in cycles 1 and 2. Once the 90Y TARE has reached the 100% dose level, the gemcitabine dose will increase to 600mg/m2 in dose level 3 and 1000mg/m2 in dose level 4. The cisplatin dose will remain at 25/mg/m2. For all dose levels, from cycle 3 to cycle 8, the cisplatin dose will be 25mg/m2 and the gemcitabine dose will be 1000mg/m2.
- interventionNames
- Device: SIR-Spheres microspheres (Yttrium-90 Microspheres)
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
- timeFrame
- Up to 2 years
- description
- A continual reassessment method (CRM) design will be used to confirm the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in regards to 90Y TARE.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon. * No prior liver radiation therapy or immunotherapy for cholangiocarcinoma. * Only one previous single agent chemotherapy for ICC allowed. * Patient may have prior liver resection. * Age \> 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (see Appendix E) * Child's Pugh score of A (see Appendix F) * Life expectancy of greater than 4 months * Normal organ and marrow function as outlined in the protocol. * Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for \> 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide). * Patients with well controlled HIV infection are eligible if their CD4 count is \>499/cu mm and viral load is \< 50 copies/ml. * Pre-certification for the 90Y TARE should be performed prior to enrollment on this study. * All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier. * Patients may not be receiving any other investigational agents. * Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria * Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C * Pregnant women are excluded from this study.
References
Publications (0)
Data not yet available
No reference posted for this study.