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Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01648023
Acronym
DELTIC
Enrollment
49
Registered
2012-07-24
Start date
2012-07-31
Completion date
2019-09-30
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Keywords

LC Bead, Irinotecan, ONCOZENE BEAD

Brief 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.

Interventions

DEVICELC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
DRUGGem-Cis or Gem-Carbo

Sponsors

Robert C. Martin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: * 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, * 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 Exclusion: * 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)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.

Secondary

MeasureTime frameDescription
Overall Survival4.5 YearsLong-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo
Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
24
Randomization to Gem-Cis or Gem-Carbo
Gem-Cis or Gem-Carbo alone Gem-Cis or Gem-Carbo
22
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyScreen Fail Post Randomization12

Baseline characteristics

CharacteristicRandomization to Gem-Cis or Gem-CarboTotalRandomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants18 Participants9 Participants
Age, Categorical
Between 18 and 65 years
13 Participants28 Participants15 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants5 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
19 Participants40 Participants21 Participants
Sex: Female, Male
Female
13 Participants26 Participants13 Participants
Sex: Female, Male
Male
9 Participants20 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
17 / 2416 / 22
other
Total, other adverse events
24 / 2419 / 22
serious
Total, serious adverse events
21 / 2419 / 22

Outcome results

Primary

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.

Time frame: Assessed at 2, 4 and 6 months. 6 months reported.

ArmMeasureValue (NUMBER)
Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-CarboTumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)24 participants
Randomization to Gem-Cis or Gem-CarboTumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)22 participants
Secondary

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.

Time frame: 4.5 Years

Population: All randomized subjects who receive at least one cycle of intravenous chemotherapy or LC or ONCOZENE beads loaded with irinotecan. Subjects will be grouped according to their randomization.

ArmMeasureValue (MEDIAN)
Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-CarboOverall Survival33.7 Months
Randomization to Gem-Cis or Gem-CarboOverall Survival12.6 Months

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026