Advanced Hepatocellular CarcinomaPhase 1NCT04417764
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.
A Phase 1 study testing Transcatheter arterial chemoembolization and PD-1 knockout engineered T cells in people with Advanced Hepatocellular Carcinoma, run by Central South University at 1 site in China.
Trial summary
This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Transcatheter arterial chemoembolization and PD-1 knockout engineered T cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2019to 31 Dec 2024
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unresectable hepatocellular carcinoma;
- More than 18 years old;
- Patients diagnosed with hepatocellular carcinoma by histopathology or imagings;
- Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points;
- Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis;
- Other organs of the whole body function well;
- Sign the informed consent;
- Passed the review by the ethics committee.
Who cannot join
- Less than 18 or more than 70 years old;
- Lack of autonomous decision-making ability;
- ECOG score >2, cachexia or multiple organ failure;
- Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months.
- Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant;
- Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution;
Show all 13Show fewer
- The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation;
- Severe infection; AIDS, syphilis infection;
- T cell lymphoma;
- Patients with mental illness, severe trauma or other stress conditions;
- Pregnant or nursing women;
- Abnormal peripheral blood routine detection;
- Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 3rd Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xiaoqian Ma, MD, 86-0731-88618413, 85316745@qq.com
About this study
Official title: Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.
This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.
Read the detailed description
This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Paitents with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic andnecrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. biomarkers and immunological markers will be monitored.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Transcatheter arterial chemoembolization, PD-1 knockout engineered T cells
- Keywords
- CRISPR Cas 9, TACE, PD-1 knockout engineered T cells, Advanced hepatocellular carcinoma, Locally administered treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial chemoembolizationProcedure or surgery
The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).
PD-1 knockout engineered T cellsBiological
The PD-1 knockout engineered T cells are prepared from autologous origin using CRISPR Cas9 technology. The patients are plan to receive 3 or more cycles of PD-1 knockout engineered T cells infusion by percutaneous fine needle liver puncture with a 4-weeks interval. A total of 1 to 3× 10^9 PD-1 edited T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent.
| Study group | Role | What they receive |
|---|---|---|
| TACE combined PD-1 knockout T cell treatment | Experimental | Not described Receives: Procedure: Transcatheter arterial chemoembolization; Biological: PD-1 knockout engineered T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.
Measured: up to 2 years
Secondary outcomes (5)
Response Rate
To evaluate the objective response rate (ORR) ,refers to the proportion of patients whose tumors shrink to a certain extent and remain unchanged for a certain period of time, including patients with CR+PR.Tumors are assessed at baseline, the 8th week, the 16th week,the 24th week, and once every 12 weeks during the treatment and follow-up period per RECIST1.1.
Measured: up to 12 months
Time to First Response
To evaluate time to first response, defined as the time from the first cell infusion to the first observed complete response (CR) or partial response (PR).
Measured: up to 2 years
Duration of Response
To evaluate the duration of response (DOR), defined as the time from the first observed CR or PR to the first observed PD or death from any cause.
Measured: up to 2 years
Progression Free Survival
To evaluate the progression free survival (PFS), defined as the time from the first cell infusion to the first observed PD or death from any cause.
Measured: up to 2 years
Overall Survival
To evaluate the overall survival (OS), defined as the time from the first cell infusion to death.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start20 Jun 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang,MD, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417764
- Sponsor's protocol ID
- CellTransplant&GeneTherapy2020
- Status last verified
- Feb 2023
- First submitted
- 29 May 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT04417764
- Acronym / sponsor ID
- CellTransplant&GeneTherapy2020
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- CRISPR Cas 9, TACE, PD-1 knockout engineered T cells, Advanced hepatocellular carcinoma, Locally administered treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jun 2020 (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.
This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.
Detailed description
This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Paitents with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic andnecrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. biomarkers and immunological markers will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combined PD-1 knockout T cell treatment | Experimental | Procedure: Transcatheter arterial chemoembolization, Biological: PD-1 knockout engineered T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with unresectable hepatocellular carcinoma;
- More than 18 years old;
- Patients diagnosed with hepatocellular carcinoma by histopathology or imagings;
- Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points;
- Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis;
Key exclusion criteria (13 listed)
- Less than 18 or more than 70 years old;
- Lack of autonomous decision-making ability;
- ECOG score >2, cachexia or multiple organ failure;
- Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months.
- Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant;
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 |
|---|---|---|
| Transcatheter arterial chemoembolizationThe patients are plan to operated by Transcatheter arterial chemoembolization(TACE). | Procedure or surgery | TACE combined PD-1 knockout T cell treatment |
| PD-1 knockout engineered T cellsThe PD-1 knockout engineered T cells are prepared from autologous origin using CRISPR Cas9 technology. The patients are plan to receive 3 or more cycles of PD-1 knockout engineered T cells infusion by percutaneous fine needle liver puncture with a 4-weeks interval. A total of 1 to 3× 10^9 PD-1 edited T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent. | Biological | TACE combined PD-1 knockout T cell treatment |
Primary outcome
Incidence of Adverse Events
Time frame: up to 2 years
Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.
5 secondary outcomes
Response Rate
Time frame: up to 12 months
Time to First Response
Time frame: up to 2 years
Duration of Response
Time frame: up to 2 years
Progression Free Survival
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
RecruitingObservational study
Observational Study Protocol: LIVER-R
Hepatobiliary Cancers
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingPhase 1
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcatheter arterial chemoembolization and PD-1 knockout engineered T cells in people with Advanced Hepatocellular Carcinoma, run by Central South University 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 8 inclusion and 13 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 9 Feb 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wei Wang, MD (86-0731-88618411, cjr.wangwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: up to 2 years). 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 9 Feb 2023.