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Trial Title:
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
NCT ID:
NCT05962450
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Block randomization was performed by the independent masked statistician. Two independent
masked radiologist who are blinded to patients' clinical information will review the
imaging examinations.
Intervention:
Intervention type:
Biological
Intervention name:
iNKT Cells
Description:
the iNKT cells will be intravenous infused every two weeks as a course of treatment for
up to six courses , the reinfusion dose is determined according to the patient's body
surface area, which was about 108~109cells/m2.
Arm group label:
RPI group
Other name:
Vα24+ T Cells
Intervention type:
Drug
Intervention name:
PD-1
Description:
Intravenous infusion, according to the drug instructions.
Arm group label:
RP group
Arm group label:
RPI group
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
Oral administration, according to the drug instructions.
Arm group label:
RP group
Arm group label:
RPI group
Summary:
The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT
cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with
PD-1 antibody. The main question it aims to answer are:
- the efficacy of autologous iNKT cells in patients with progressed HCC after
treatment with PD-1 antibody.
- the safety of autologous iNKT cells in patients with progressed HCC after treatment
with PD-1 antibody.
Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI
group) or the treatment of Regorafenib + PD-1 (RP group).
Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve
a better therapeutic effect on HCC patients with PD-1 resistance.
Detailed description:
Single center, randomized, open trial in Barcelona Clinic Liver Cancer（BCLC）C stage
patients with progressed HCC after anti-angiogenic targeted drugs combined with PD-1
monoclonal antibody therapy to explore the efficacy and safety of autologous iNKT cells.
This study includes screening period, treatment period and follow-up period (until the
subjects withdrew their informed consent or received other anti-tumor therapy or
participated in other clinical trials or the researchers judged that it is not in the
best interests of patients to continue to participate in the study) after treatment.
The patients will be randomized 1:1 using a random number table to receive Regorafenib +
PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group).
1. iNKT Cells：Intravenous infusion. The cells will be infused every two weeks as a
course of treatment for up to six courses.
2. PD-1：Intravenous infusion, according to the drug instructions.
3. Regorafenib：Oral administration, according to the drug instructions. All target and
non-target lesions will be assessed by chest, abdomen, and pelvis CT or MRI at
baseline and every 8 weeks until radiological progression (according to
mRECIST/iRECIST).
Safety and side-effect profiles will be assessed based on the nature, frequency, and
severity of adverse events, according to the National Cancer Institute (NCI) Common
Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-75 years of age.
- Barcelona Clinic Liver Cancer（BCLC） C stage hepatocellular carcinoma (HCC) confirmed
by CT, MRI, and/or histopathology.
- Progressed after receiving anti-angiogenic targeted drugs combined with PD-1
monoclonal antibody.
- Life expectancy of at least 12 weeks.
- Child-Pugh A/B.
- Voluntary signing of informed consent.
Exclusion Criteria:
- History of severe hypertension or cardiac disease.
- known central nervous system (CNS) tumor or combined with other malignant disorders.
- Uncontrolled immune system or infectious disease.
- Known history of the human immunodeficiency virus (HIV) or syphilis infection.
- History of stem cell transplant or organ allograft.
- History of allergy to immunotherapy or related drugs.
- Bilirubin is twice times the upper limit of normal.
- Glomerular filtration rate （GFR）< 60ml/min.
- Serious complications include moderate or severe infective pleural and peritoneal
effusion, pericardial effusion, upper gastrointestinal bleeding, hepatic
encephalopathy.
- Pregnancy or lactation.
- History of severe allergy to any monoclonal antibody or anti-angiogenic targeted
drug.
- Deemed not suitable for cellular immunotherapy by the investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Youan Hospital,Capital Medical University
Address:
City:
Beijing
Zip:
100069
Country:
China
Status:
Recruiting
Contact:
Last name:
Songtao Liu, MD.
Phone:
86-13811120755
Email:
botao8080@163.com
Start date:
October 26, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Beijing YouAn Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Gene Key Life Technology Co., Ltd.
Agency class:
Other
Source:
Beijing YouAn Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05962450
