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.
New cancer therapy combines TACE with engineered T cells for advanced liver cancer.
Plain English Summary
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma. is a Phase 1 clinical trial sponsored by Central South University studying Advanced Hepatocellular Carcinoma. This trial tests a new combination therapy for advanced liver cancer, using a standard procedure (TACE) with a novel cell-based treatment. It is designed for patients with advanced, unresectable liver cancer who meet specific health and tumor criteria. Participation involves receiving the combination therapy and undergoing regular monitoring; blood and tissue samples may also be collected. Alternative treatments for advanced liver cancer include other systemic therapies, targeted drugs, or palliative care. The trial aims to enroll 10 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with advanced liver cancer that cannot be surgically removed can join. You must be over 18 years old and generally healthy, with good liver function and no widespread metastasis. Specific tumor size and number limits apply, and you must not have major blood clotting issues or severe autoimmune diseases. Individuals under 18, over 70, with severe organ failure, certain infections, or pregnant/nursing women cannot participate. This trial is studying Advanced Hepatocellular Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the frequency of side effects, indicating how safe the new treatment combination is for patients. The specific primary outcome measures are: Incidence of Adverse Events (up to 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a significant unmet need in advanced liver cancer by exploring a novel combination therapy that aims to improve treatment outcomes for patients with limited options. This research targets Advanced Hepatocellular Carcinoma, where improved treatment options are needed.
Investor Insight
This Phase 1 trial, while early stage, explores a cutting-edge immunotherapy approach for a common cancer, signaling potential for future advancements in a large market. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of both TACE and the engineered T cell therapy. Understand the treatment schedule, including the number of TACE procedures and T cell infusions, and the frequency of follow-up appointments. Be prepared for potential side effects and discuss how they will be managed throughout the trial. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- PROCEDURE: Transcatheter arterial chemoembolization — The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).
- BIOLOGICAL: PD-1 knockout engineered T cells — 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.
Primary Outcomes
- Incidence of Adverse Events (up to 2 years)
Secondary Outcomes
- Response Rate (up to 12 months)
- Time to First Response (up to 2 years)
- Duration of Response (up to 2 years)
- Progression Free Survival (up to 2 years)
- Overall Survival (up to 2 years)
Full Eligibility Criteria
Inclusion Criteria: 1. Patients with unresectable hepatocellular carcinoma; 2. More than 18 years old; 3. Patients diagnosed with hepatocellular carcinoma by histopathology or imagings; 4. Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points; 5. Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis; 6. Other organs of the whole body function well; 7. Sign the informed consent; 8. Passed the review by the ethics committee. Exclusion Criteria: 1. Less than 18 or more than 70 years old; 2. Lack of autonomous decision-making ability; 3. ECOG score \>2, cachexia or multiple organ failure; 4. Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months. 5. Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant; 6. Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution; 7. The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation; 8. Severe infection; AIDS, syphilis infection; 9. T cell lymphoma; 10. Patients with mental illness, severe trauma or other stress conditions; 11. Pregnant or nursing women; 12. Abnormal peripheral blood routine detection; 13. Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.
Trial Locations
- The 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China
Frequently Asked Questions
What is clinical trial NCT04417764?
NCT04417764 is a Phase 1 INTERVENTIONAL study titled "TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.." It is currently unknown and is sponsored by Central South University. The trial targets enrollment of 10 participants.
What conditions does NCT04417764 study?
This trial investigates treatments for Advanced Hepatocellular Carcinoma. The primary condition under study is Advanced Hepatocellular Carcinoma.
What treatments are being tested in NCT04417764?
The interventions being studied include: Transcatheter arterial chemoembolization (PROCEDURE), PD-1 knockout engineered T cells (BIOLOGICAL). The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).
What does Phase 1 mean for NCT04417764?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT04417764?
This trial is currently "Unknown." It started on 2019-06-20. The estimated completion date is 2024-12-31.
Who is sponsoring NCT04417764?
NCT04417764 is sponsored by Central South University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04417764?
The trial aims to enroll 10 participants. The trial status is unknown.
How is NCT04417764 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04417764?
The primary outcome measures are: Incidence of Adverse Events (up to 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04417764 being conducted?
This trial is being conducted at 1 site, including Changsha, Hunan (China).
Where can I find official information about NCT04417764?
The official record for NCT04417764 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04417764. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04417764 testing in simple terms?
This trial tests a new combination therapy for advanced liver cancer, using a standard procedure (TACE) with a novel cell-based treatment. It is designed for patients with advanced, unresectable liver cancer who meet specific health and tumor criteria.
Why is this trial significant?
This trial addresses a significant unmet need in advanced liver cancer by exploring a novel combination therapy that aims to improve treatment outcomes for patients with limited options.
What are the potential risks of participating in NCT04417764?
Common side effects of TACE can include pain, fever, and nausea. The engineered T cell therapy may cause immune-related side effects, such as fatigue or flu-like symptoms. There is a risk of infection or bleeding at the infusion site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04417764?
Ask your doctor about the specific risks and benefits of both TACE and the engineered T cell therapy. Understand the treatment schedule, including the number of TACE procedures and T cell infusions, and the frequency of follow-up appointments. Be prepared for potential side effects and discuss how they will be managed throughout the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04417764 signal from an investment perspective?
This Phase 1 trial, while early stage, explores a cutting-edge immunotherapy approach for a common cancer, signaling potential for future advancements in a large market. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving the combination therapy and undergoing regular monitoring; blood and tissue samples may also be collected. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.