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New treatment option for Advanced Hepatocellular Carcinoma
Official title Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT05620706
What this study is testing
What is GPC3 CAR-T cells?
GPC3 CAR-T cells is an investigational medicine, being studied as a potential treatment for advanced hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- 40\~70 years old;
- Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, who are not suitable for surgery or local treatment...
- Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;
- At least one target lesion that can be evaluated stably according to RECIST 1.1 standard is defined as: the longest diameter of non lymph node...
- Tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC);
You likely can't join if
- Pregnant or lactating women;
- HCV-RNA, HIV antibody or syphilis antibody are positive;
- Any uncontrollable active infection, including but not limited to active tuberculosis;
- Have received systemic steroids equivalent to\>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;
- Allergies to immunotherapy and related drugs, previous severe allergies β- Allergy to lactam antibiotics;
- Previous or current hepatic encephalopathy;
See the full eligibility criteria
- 40\~70 years old;
- Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, who are not suitable for surgery or local treatment (including ablation therapy, treatment therapy and radiotherapy), and...
- Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;
- At least one target lesion that can be evaluated stably according to RECIST 1.1 standard is defined as: the longest diameter of non lymph node lesions ≥ 10mm, or the short diameter of lymph node lesions ≥ 15mm...
- Tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC);
- Grade C according to Barcelona liver cancer grading standard (BCLC) or Grade B which is not suitable for local treatment/progression of local treatment;
- Estimated survival time \> 12 weeks;
- Cirrhotic state Child Pugh score Grade A
- ECOG physical status score 0\~1;
- If the patient is HBsAg positive or HBcAb positive, HBV-DNA\<200IU/ml. HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);
- Single vein access;
- Blood routine test: WBC ≥ 2.5 × 109/L， PLT≥60 × 109/L， Hb≥9.0 g/dL，LY≥0.4 × 109/L；
- Blood biochemistry: serum Alb ≥ 30 g/L, serum lipase and amylase ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance rate ≥ 40mL/min, ALT ≤ 5ULN, AST ≤ 5ULN, total bilirubin ≤ 2.5ULN, prothrombin...
- The women of childbearing age must carry out serum pregnancy test within the screening period and 14 days before starting the study medication, and the result is negative. They are willing to use reliable methods of...
- Be able to understand and sign the informed consent form HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015); 11\. Single...
- Pregnant or lactating women;
- HCV-RNA, HIV antibody or syphilis antibody are positive;
- Any uncontrollable active infection, including but not limited to active tuberculosis;
- Have received systemic steroids equivalent to\>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;
- Allergies to immunotherapy and related drugs, previous severe allergies β- Allergy to lactam antibiotics;
- Previous or current hepatic encephalopathy;
- At present, there is ascites with clinical significance, which is defined as: ascites with positive signs on physical examination or ascites that need to be controlled by intervention (such as puncture or drug therapy)...
- Imaging examination results: the proportion of liver being replaced by tumor ≥ 50%, or portal trunk tumor thrombus, or tumor thrombus invading mesenteric vein/inferior vena cava;
- Central nervous system metastasis and diseases of central nervous system with clinical significance;
- At present, there is a heart disease that needs treatment or hypertension that is judged by the researcher to be poorly controlled (systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg);
- Patients with known active autoimmune diseases need to be treated with immunosuppressants including biological agents;
- Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
- Have received treatment for the study disease within 2 weeks before single collection, including but not limited to surgical treatment, treatment treatment, radiotherapy, chemotherapy and immunotherapy;
- Received targeted GPC3 treatment, TCR-T treatment and CAR-T treatment in the past month;
- Being treated with anti PD-1/PD-L1 monoclonal antibody in the past 28 days;
- Other incurable malignant tumors in the past 5 years or at the same time, excluding cervical carcinoma in situ and skin basal cell carcinoma;
- Other serious diseases that may restrict the people from participating in this trial (such as diabetes under poor control (HbA1c\>7% after treatment), severe cardiac insufficiency (LVEF\<45%), myocardial infarction or...
- The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.