Clinical trial NCT03983967: Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation
Official title: Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Transplantation
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-12
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.

Detailed description: ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.

For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients who are more than 20 and less than 80 years old.
* Patients whose expected life expectancy is at least 16 weeks (4 months).
* Patients who receive liver transplants exceeding the Milan Criteria.
* ECOG Performance Status (ECOG-PS) score is 0-2.
* Patients who satisfy the following conditions of the blood test and kidney, liver function test.

Absolute neutrophil count \> 500x10\^6L Hemoglobin ≥ 7.5 g/dL Platelet count \> 20,000/㎣ Total bilirubin \< 15mg/㎗

•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.

Exclusion Criteria:

* Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
* Patients who undergo ABO incompatible Liver Transplantation.
* Patients who had previously administered cell therapy.
* Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
* Patients who are currently receiving dialysis.
* Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date.
* Patients who have uncontrollable or serious disease.
* Patients who are unable to use appropriate methods of contraception during the study period.
* Patient whose tumor has not been removed or liver metastasis is confirmed.

Primary outcomes:
measure: maximum tolerated dose (MTD) or maximum feasible dose (MFD)
timeFrame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Secondary outcomes:
measure: Time to Recurrence
timeFrame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
measure: Recurrence-Free Survival
timeFrame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
measure: Overall Survival
timeFrame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Suk Suh, MD
role: PRINCIPAL_INVESTIGATOR
References: