single-arm, open-label clinical study of sz003 in the treatment of advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: this study was a single-center, open-label, investigator-initiated clinical trial (iit) to observe and investigate the clinical safety and efficacy of sz003 in the treatment of advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. with advanced hepatocellular carcinoma (hcc) confirmed by histopathology; 2. with stage c according to the barcelona liver cancer grading criteria (bclc) or with stage b who are ineligible for locoregional/locoregional therapy progression; 3. unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy; 4. through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (gpc3) ; 5. with at least one stable evaluable target lesion according to recist 1.1 criteria, which was defined as: non-nodal lesion longest diameter ≥10 mm, or nodal lesion short diameter ≥15 mm; 6. age 18-80, male or female; 7. karnofsky performance status (kps)≥80; 8. stable vital signs and expected survival at least 12 weeks. 9. if hbsag or hbcab is positive, hbv-dna \< 200 iu/ml and to receive anti-hbv therapy ((entecavir or tenofovirdisoproxil) for at least 14 days prior to the start of study treatment; 10. blood routine: wbc≥2.5×109/l, plt≥60×109/l, hb≥9.0g/dl, ly≥0.4×109/l; 11. blood biochemistry: alb≥30g/l, lipase and amylase ≤1.5 uln, serum creatinine ≤1.5 uln, creatinine clearance ≥40ml/min, alt≤5 uln, ast≤5 uln, total serum bilirubin ≤2.5 uln, prothrombin time ≤6s; 12. be able to understand and sign an informed consent form exclusion criteria: 1. with uncontrolled active infections; 2. no other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation. 3. with previous history of encephalopathy. 4. with active acute or chronic virus, germ infection; 5. diagnosed with hiv infection or active hepatitis, hbv, hcv infection or other serious infectious diseases; 6. other serious medical conditions that may limit participation in the trial (such as poorly controlled diabetes (treated glycated hemoglobin hba1c \> 7%) , severe heart failure (left ventricular ejection fraction (lvef) \< 45%) , myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary function test fev1 \< 60% predicted, gastric ulcer, history of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency) ; 7. ascites more than 5cm; 8. the proportion of liver replaced by tumor≥70%, or with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver; 9. prior solid organ transplantation or waiting for organ transplantation (including liver transplantation); 10. prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy. 11. long-term systemic steroid therapy or patients with autoimmune diseases; 12. with a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study; 13. have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation. 14. had received cell therapy previously but ineffective,after physical examination not allowed to received car-nk therapy by investigator's judgement; 15. pregnant or lactating women; 16. inappropriate to participate in this clinical trial by investigator's judgement.