Status:
UNKNOWN
GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
Brief Summary
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment....
Eligibility Criteria
Inclusion
- GPC3 positive HCC, tumor size \>= 5 cm, cannot receive standard treatment, Expected survival time\>=3 months.
- Routine blood test: white blood cell count（WBC)\>= 2.5×10\^9/L, hemoglobin (Hb)\>= 9.0 g/dL, blood platelet \>= 60×10\^9/L, Lymphocyte percentage\>=15%.
- Blood biochemical parameters: ALB \>= 30 g/L, ALT \<= 5 times of the normal value, AST \<= 5 times of the normal value, serum lipase\<=1.5 times of the normal value, serum amylase\<=1.5 times of the normal value， total bilirubin \<= 2.5 times of the normal value.
- Prothrombin time INR \< 1.7.
- Ejection fraction (EF) \>= 55%, oxygen saturation (SO2) \> 90%.
- No allergic reaction to contrast material.
- Karnofsky score \>= 60%.
- Child-puge score \<7.
- Peripheral venous access.
- Voluntarily signed informed consent.
Exclusion
- Pregnancy or lactation.
- Systemic steroid treatment ( \>prednisone equivalent/kg/day).
- Patients with previous history of cell immunotherapy or antibody therapy.
- Patients received radiotherapy/chemotherapy in the past 4 weeks.
- Patients are participating in other clinical trials.
- Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
- Patients with acute allergic reaction.
- History of liver transplantation.
- Patients with anticoagulant treatment.
- Patients with hepatic encephalopathy.
- Eligible for hepatectomy, liver transplantation or other standard treatment.
- Unstable gastrointestinal and respiratory bleeding.
- Active viral, fungal or bacterial infections.
- Heart failure classification (NYHA): II-IV.
- Patients are unable or unwilling to comply with the requirements of the study protocol.
- Patients do not meet the criteria above.
Key Trial Info
Start Date :
October 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04121273
Start Date
October 5 2019
End Date
November 1 2021
Last Update
March 3 2021
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008