Unresectable Intrahepatic CholangiocarcinomaPhase 2DELTICNCT01648023
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin
A Phase 2 study testing LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo and Gem-Cis or Gem-Carbo in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Robert C. Martin at 1 site in United States.
Trial summary
The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Intrahepatic Cholangiocarcinoma
- What is being tested?
- LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo and Gem-Cis or Gem-Carbo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible
- Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)
- Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver
- Non-pregnant with an acceptable contraception in premenopausal women.
- Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria)
- Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,
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- Adequate renal function (creatinine ≤ 2.3 mg/dl)
- Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age)
- Signed, written informed consent
- Less than 70% of liver parenchymal tumor replacement
Who cannot join
- Patient eligible for curative treatment (i.e. resection or tumor ablation).
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- ECOG Performance Status score of >3
- Life expectancy of < 3 months
- Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated
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- Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin.
- Any contraindication for hepatic embolization procedures:
- Large shunt as determined by the investigator (pretesting with TcMMA not required)
- Severe atheromatosis vascular disease that precludes arterial cannulization
- Hepatofugal blood flow
- Main portal vein occlusion (e.g. thrombus or tumor)
- Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
- Patients with prior contraindications for the use of irinotecan, gemcitabine, or cisplatin
- Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
- Being tested
- LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo, Gem-Cis or Gem-Carbo
- Keywords
- LC Bead, Irinotecan, ONCOZENE BEAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC or ONCOZENE Bead with Gem-Cis or Gem-CarboDevice
Gem-Cis or Gem-CarboDrug
| Study group | Role | What they receive |
|---|---|---|
| Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo | Experimental | Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo Receives: Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo |
| Randomization to Gem-Cis or Gem-Carbo | Active comparator | Gem-Cis or Gem-Carbo alone Receives: Drug: Gem-Cis or Gem-Carbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will be classified as: Complete Response - disappearance of all lesions; Partial Response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter or 30% reduction in arterial enhancement; Progressive Disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
Measured: Assessed at 2, 4 and 6 months. 6 months reported.
Secondary outcomes (1)
Overall Survival
Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death.
Measured: 4.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unresectable Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert C. Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648023
- Sponsor's protocol ID
- 11-0181
- Acronym
- DELTIC
- Status last verified
- Dec 2021
- First submitted
- 17 Jul 2012
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01648023
- Acronym / sponsor ID
- DELTIC / 11-0181
- Keywords
- LC Bead, Irinotecan, ONCOZENE BEAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Robert C. MartinUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 13 Jan 2022
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 find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo | Experimental | Device: LC or ONCOZENE Bead with Gem-Cis or Gem-CarboTransarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo |
| Randomization to Gem-Cis or Gem-Carbo | Active comparator | Drug: Gem-Cis or Gem-CarboGem-Cis or Gem-Carbo alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible
- Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)
- Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver
- Non-pregnant with an acceptable contraception in premenopausal women.
- Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria)
Key exclusion criteria (15 listed)
- Patient eligible for curative treatment (i.e. resection or tumor ablation).
- Active bacterial, viral or fungal infection within 72 hours of study entry
- Women who are pregnant or breast feeding
- ECOG Performance Status score of >3
- Life expectancy of < 3 months
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 |
|---|---|---|
| LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo | Device | Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo |
| Gem-Cis or Gem-Carbo | Drug | Randomization to Gem-Cis or Gem-Carbo |
Primary outcome
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)
Time frame: Assessed at 2, 4 and 6 months. 6 months reported.
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will be classified as: Complete Response - disappearance of all lesions; Partial Response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter or 30% reduction in arterial enhancement; Progressive Disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
1 secondary outcome
Overall Survival
Time frame: 4.5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Martin, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo and Gem-Cis or Gem-Carbo in people with Unresectable Intrahepatic Cholangiocarcinoma, run by Robert C. Martin 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 27 Feb 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease) (time frame: Assessed at 2, 4 and 6 months. 6 months reported.). 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 27 Feb 2025.