90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02512692
• Other study ID #: 102254
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: August 31, 2022
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Device:
• SIR-Spheres microspheres (Yttrium-90 Microspheres)
On Day 3 or 4 of cycle 1 90Y TARE will be administered

Drug:
• Gemcitabine
On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles
• Cisplatin
On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of a dose limiting toxicity (DLT) of 90Y TARE in combination with gemcitabine and cisplatin.	A continual reassessment method (CRM) design will be used to identify the maximum-tolerated dose (MTD)	6 weeks of study treatment