Clinical trial NCT05845502: Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
Official title: Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
Collaborators: name: Guangdong ProCapZoom Biosciences Co., Ltd.
First posted: 2023-05-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: The incidence rates and severity of AEs
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: overall survival (OS)
timeFrame: up to 2 years
measure: progression-free survival (PFS)
timeFrame: up to 2 years
measure: disease control rate (DCR) and objective response rate (ORR)
timeFrame: up to 2 years
measure: duration of response (DOR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou University Medical College
state: Guangdong
Study officials:
References: