Hepatocellular CarcinomaPhase 2NCT05962450
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
A Phase 2 study testing iNKT Cells, PD-1 and Regorafenib in people with Hepatocellular Carcinoma, run by Beijing YouAn Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- iNKT Cells, PD-1 and Regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to 1 Aug 2025
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
Songtao Liu, MD., 86-13811120755, botao8080@163.com
About this study
Official title: An Open Label, Randomized, Controlled, Clinical Trial of Adoptive Autologous Invariant Natural Killer T Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
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.
Read more
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.
Read the 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).
- iNKT Cells：Intravenous infusion. The cells will be infused every two weeks as a course of treatment for up to six courses.
- PD-1：Intravenous infusion, according to the drug instructions.
- 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- iNKT Cells, PD-1, Regorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNKT CellsBiological
Also called Vα24+ T Cells
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.
PD-1Drug
Intravenous infusion, according to the drug instructions.
RegorafenibDrug
Oral administration, according to the drug instructions.
| Study group | Role | What they receive |
|---|---|---|
| RPI group | Experimental | Regorafenib + PD-1 + iNKT cells Receives: Biological: iNKT Cells; Drug: PD-1; Drug: Regorafenib |
| RP group | Other | Regorafenib + PD-1 Receives: Drug: PD-1; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time from enrollment to disease progression according to the modified RECIST (mRECIST) guideline in trial immunotherapeutics, or death from any cause, whichever occurred first；the time from enrollment to confirmed disease progression (iCPD) according to the iRECIST
Measured: The time from enrollment to disease progression, or death from any cause, whichever occurred first, up to 24 months.
Secondary outcomes (7)
Disease control rate (DCR)
including complete response (CR), partial response (PR), and disease stabilization (SD), evaluated by imaging according to iRECIST for target lesions and assessed by MRI/CT.
Measured: Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.
Objective response rate (ORR)
complete response (CR) and partial response (PR) evaluated by imaging according to mRECIST/iRECIST for target lesions and assessed by MRI/CT.
Measured: Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.
Overall survival (OS)
Time from the date of enrollment to the date of death from any cause.
Measured: Time from the date of enrollment to the date of death from any cause, up to 36 months.
1-year overall survival rate (1-year OS rate)
The proportion of subjects who were still alive from the date of enrollment to 1 year later
Measured: Time from the date of enrollment to 1 year later.
Duration of Overall Response (DOR)
The time from the first tumor remission (CR or PR according to mRECIST/iRECIST) to the first recording of disease progression (PD according to mRECIST criteria or iCPD according to iRECIST) or death from any cause (whichever occurs first).
Measured: Time from the first tumor remission to the first recording of disease progression or death from any cause, up to 24 months..
Time to progression (TTP)
Time from the date of enrollment to the date of first disease progression (PD) according to mRECIST or iCPD according to iRECIST).
Measured: Time from the date of enrollment to the date of first disease progression, up to 24 months.
Time to Quality of Life (QoL) Deterioration
EORTC QLQ-C30: European Organization for Research on Treatment of Cancer Quality of Life Questionnare-Core 30.
The totally 30 items spread out over five functional scales (15 items), three symptom scales (7 items), a global health status/QoL scale (2 items), and six single items. 1-28 item ranges 1: not at all, 2: a little, 3: quite a lit, 4: very much; 29-30 item ranges 1-7 from very poor to excellent. Raw score (RS) is an average of all items in each area. Standardized score is in the range of 0-100 by formula SS=[1-(RS-1)/n] x100 (function) or SS=[（RS-1）/n]x100 (symptom or overall health) respectively. A high scale score represents a higher/healthy response level.
Time to deterioration was defined as a decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments.
Measured: Time from the date of enrollment, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start26 Oct 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing YouAn Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Gene Key Life Technology Co., Ltd
- Responsible party
- Principal investigator, LU JUN, Beijing YouAn Hospital
- Investigators
- Jun Lu, MD., Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962450
- Sponsor's protocol ID
- Beijing YouAn Ethics [2023]060
- Status last verified
- Jan 2024
- First submitted
- 4 Jul 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Controlled, Clinical Trial of Adoptive Autologous Invariant Natural Killer T Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT05962450
- Acronym / sponsor ID
- Beijing YouAn Ethics [2023]060
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing YouAn HospitalUniversity, hospital or other
- Collaborators
- Beijing Gene Key Life Technology Co., Ltd
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- 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 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).
- iNKT Cells：Intravenous infusion. The cells will be infused every two weeks as a course of treatment for up to six courses.
- PD-1：Intravenous infusion, according to the drug instructions.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPI group | Experimental | Biological: iNKT Cells, Drug: PD-1, Drug: RegorafenibRegorafenib + PD-1 + iNKT cells |
| RP group | Other | Drug: PD-1, Drug: RegorafenibRegorafenib + PD-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| iNKT CellsAlso: Vα24+ T Cellsthe 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. | Biological | RPI group |
| PD-1Intravenous infusion, according to the drug instructions. | Drug | RP group, RPI group |
| RegorafenibOral administration, according to the drug instructions. | Drug | RP group, RPI group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: The time from enrollment to disease progression, or death from any cause, whichever occurred first, up to 24 months.
The time from enrollment to disease progression according to the modified RECIST (mRECIST) guideline in trial immunotherapeutics, or death from any cause, whichever occurred first；the time from enrollment to confirmed disease progression (iCPD) according to the iRECIST
7 secondary outcomes
Disease control rate (DCR)
Time frame: Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.
Objective response rate (ORR)
Time frame: Evaluation was performed every 8 weeks after the start of the treatment, up to 24 months.
Overall survival (OS)
Time frame: Time from the date of enrollment to the date of death from any cause, up to 36 months.
1-year overall survival rate (1-year OS rate)
Time frame: Time from the date of enrollment to 1 year later.
Duration of Overall Response (DOR)
Time frame: Time from the first tumor remission to the first recording of disease progression or death from any cause, up to 24 months..
Time to progression (TTP)
Time frame: Time from the date of enrollment to the date of first disease progression, up to 24 months.
Time to Quality of Life (QoL) Deterioration
Time frame: Time from the date of enrollment, up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Jun Lu, MD. principal investigator
Beijing YouAn Hospital
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 iNKT Cells, PD-1 and Regorafenib in people with Hepatocellular Carcinoma, run by Beijing YouAn Hospital at 1 site in China.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Lu, MD. (86-13661381489, lujun98@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: The time from enrollment to disease progression, or death from any cause, whichever occurred first, up to 24 months.). 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 16 Jan 2024.