Intrahepatic CholangiocarcinomaNCT02512692
Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
A study testing SIR-Spheres microspheres (Yttrium-90 Microspheres), Gemcitabine and Cisplatin in people with Intrahepatic Cholangiocarcinoma, run by Medical University of South Carolina at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- SIR-Spheres microspheres (Yttrium-90 Microspheres), Gemcitabine and Cisplatin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2015to 19 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
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).
Read the detailed description
Gemcitabine and cisplatin chemotherapy is the current standard for the treatment of unresectable intrahepatic cholangiocarcinoma. 90Y TARE combined with the current standard may be an ideal way to improve disease control in the liver as almost all patients die from their disease in the liver. The data from this trial would then be used to move to a phase II trial to determine efficacy to see if a phase III trial would be warranted. In addition, assessment of the molecular classification of intrahepatic cholangiocarcinoma could determine if there is difference in survival with chemotherapy and 90Y TARE. Finally, MRI before and after treatment will be used to determine if utilizing the percent increase of mean ADC correlates with survival.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- SIR-Spheres microspheres (Yttrium-90 Microspheres), Gemcitabine, Cisplatin
- Keywords
- intrahepatic cholangiocarcinoma, cholangiocarcinoma, 90Y TARE, radioembolization, gemcitabine and cisplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-Spheres microspheres (Yttrium-90 Microspheres)Device
Also called 90Y TARE
On Day 3 or 4 of cycle 1 90Y TARE will be administered
GemcitabineDrug
On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles
CisplatinDrug
On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| 90Y TARE with Gemcitabine and Cisplatin | Experimental | 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. Receives: Device: SIR-Spheres microspheres (Yttrium-90 Microspheres); Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start21 Jul 2015
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Why it stopped: Enrollment closed by internal scientific review committee due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel L. Cooper, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512692
- Sponsor's protocol ID
- 102254
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2015
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02512692
- Acronym / sponsor ID
- 102254
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- intrahepatic cholangiocarcinoma, cholangiocarcinoma, 90Y TARE, radioembolization, gemcitabine and cisplatin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment closed by internal scientific review committee due to slow accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Gemcitabine and cisplatin chemotherapy is the current standard for the treatment of unresectable intrahepatic cholangiocarcinoma. 90Y TARE combined with the current standard may be an ideal way to improve disease control in the liver as almost all patients die from their disease in the liver. The data from this trial would then be used to move to a phase II trial to determine efficacy to see if a phase III trial would be warranted. In addition, assessment of the molecular classification of intrahepatic cholangiocarcinoma could determine if there is difference in survival with chemotherapy and 90Y TARE. Finally, MRI before and after treatment will be used to determine if utilizing the percent increase of mean ADC correlates with survival.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 90Y TARE with Gemcitabine and Cisplatin | Experimental | Device: SIR-Spheres microspheres (Yttrium-90 Microspheres), Drug: Gemcitabine, Drug: Cisplatin90Y 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIR-Spheres microspheres (Yttrium-90 Microspheres)Also: 90Y TAREOn Day 3 or 4 of cycle 1 90Y TARE will be administered | Device | 90Y TARE with Gemcitabine and Cisplatin |
| GemcitabineOn days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles | Drug | 90Y TARE with Gemcitabine and Cisplatin |
| CisplatinOn days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles | Drug | 90Y TARE with Gemcitabine and Cisplatin |
Primary outcome
To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
Time frame: Up to 2 years
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.
Results and safety
The study was stopped early (reason given: Enrollment closed by internal scientific review committee due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel L. Cooper, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIR-Spheres microspheres (Yttrium-90 Microspheres), Gemcitabine and Cisplatin in people with Intrahepatic Cholangiocarcinoma, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment closed by internal scientific review committee due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of 90Y TARE in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.