Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2015-06-30
2016-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC
NCT04121273
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
NCT04506983
GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
NCT03198546
Novel GPC3 CAR-T Cell Therapy for Hepatocellular Carcinoma
NCT05344664
CAR-T Cell Therapy Targeting GPC3 in Patients with Advanced GPC3-Positive Hepatocellular Carcinoma
NCT06641453
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen by infusion.
CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.
no intervention
no intervention
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Gender:both.
3. GPC3 high expression hepatocellular carcinoma patients.
4. Non diffuse hepatocellular carcinoma，no extrahepatic metastasis or portal vein vascular invasion.
5. Degree of liver cirrhosis：class A or class B 7 according to Child-puge grading standard.
6. Routine blood test：white blood cell count（WBC)\>=3×10\^9/L, Lymphocyte percentage\>=15%, hemoglobinHbo（Hb）\>=90g/L, prothrombin time（PT） prolongation\<=50% normal value, Cluster of differentiation 3(CD3) positive T cell count\>=0.8×10\^9/L.
7. Liver and Pancreatic function：Alanine aminotransferase/Aspartate transaminase(ALT/AST)\<=5 times of the normal value, total bilirubin(TBiL)\<=3.0mg/dL, albumin(ALB)\>=35g/L, prothrombin time(PT):International Normalized Ratio(INR)\<=1.7 or prothrombin time(PT) prolongation\<=4s, Serum lipase\<=1.5 times of the normal value, Serum amylase\<=1.5 times of the normal value.
8. Renal function：Serum creatinine(SCr)\<=221μmol/L(2.5mg/L).
9. Karnofsky Performance Status(KPS)\>=60；Expected survival time\>=12 weeks.
10. Peripheral venous access ；no contraindication of lymphocyte separation.
11. No other serious complications.
12. Voluntarily signed informed consent.
Exclusion Criteria
2. Lymphocyte separation or peripheral venous access cannot be performed in patients .
3. Patients in the active stage of infection or with coagulation disorders.
4. Patients with a previous history of hepatic coma.
5. Patients with severe gastrointestinal ulcers or gastrointestinal bleeding.
6. Patients with organ transplantation or waiting for organ transplantation.
7. Patients with anticoagulant therapy.
8. Patients with antiplatelet therapy.
9. Serum sodium(Na)\<125 mmol/L.
10. Serum potassium(K)\<3.5 mmol/L(except patients up to the standards after the use of supplements).
11. Patients with organ failure：
1. cardiac function：level three or above according to New York Heart Association (NYHA) criteria.
2. liver function:class C or above according to Child-puge grading standard.
3. renal function:Chronic kidney disease(CKD) phase 4 or more; renal insufficiency phase Ⅲ or more.
4. pulmonary function：severe respiratory failure symptoms, involving other organs.
5. Brain function:central nervous system abnormalities or disturbance of consciousness.
12. Patients with non controlled infectious diseases,for example,HIV positive, syphilis, hepatitis A, hepatitis B, hepatitis C, hepatitis E virus (HEV) positive etc.
13. Patients used corticosteroids or other immunosuppressive agents in the past 4 weeks.
14. Patients with autoimmune disease.
15. Patients with previous history of gene therapy.
16. The actual transfection rate of T cells was lower than 30% or the proliferation was less than 5 times after costimulation.
17. Patients participated in other drug trials in the past 4 weeks.
18. Patients received radiation treatment in the past 4 weeks.
19. Patients do not meet the criteria above.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lizhi Niu, PhD
Role: STUDY_CHAIR
Fuda Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAR-T for GPC3+ HCC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.