ClinicalTrials.gg
TerminatedNCT05845502Updated Jan 29, 2025

Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma

An interventional study of SZ003 CAR-NK in Advanced Hepatocellular Carcinoma, sponsored by Shantou University Medical College. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Shantou University Medical College · Not applicable, Interventional, and Treatment

Why this study was terminated
Failed to recruit more volunteers

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jul 2021, registered Apr 2023).

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Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,309 studies in Carcinoma, Hepatocellular with a site in China — 485 open to participants now, 557 under way, 70 of them phase 3. Carcinoma, Hepatocellular · China.

Enrollment
990th of 1,033
8 · median 78
Started
2021
with 116 others
No phase
235 of 1,309
75 open now
Registered
814th of 1,309
by date

Among the 1,309 studies in Carcinoma, Hepatocellular with a site in China, this one is the 990th largest by enrollment of the 1,033 interventional ones that give a count, is one of 117 that started in 2021, is one of 235 with no phase, and was the 814th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

485 of the 1,309 studies in Carcinoma, Hepatocellular with a site in China are open now. Recruiting first, the newest first:

480 more — sign in →

All 485 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Advanced Hepatocellular Carcinoma
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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. Performance Status (KPS)≥80;
  8. Stable vital signs and expected survival at least 12 weeks.
  9. If 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, ≥60×109/L, ≥9.0g/dL, LY≥0.4×109/L;
  11. Blood biochemistry: Alb≥30g/L, Lipase and Amylase ≤1.5 , Serum creatinine ≤1.5 ULN, ≥40mL/min, ≤5 ULN, AST≤5 ULN, Total Serum ≤2.5 ULN, ≤6s;
  12. Be able to understand and sign an form

Exclusion criteria

Exclusion Criteria:

  1. With uncontrolled active infections;
  2. No other prior 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 infection or active hepatitis, , infection or other serious infectious diseases;
  6. Other serious medical conditions that may limit participation in the trial (such as poorly controlled diabetes (treated HbA1c > 7%) , severe heart failure ( (LVEF) \< 45%) , myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, pulmonary embolism, , Interstitial lung disease, pulmonary function test \< 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 therapy or patients with 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 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.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    SZ003 CAR-NK

    Biological: SZ003 CAR-NK

Interventions

  • BiologicalSZ003 CAR-NK

    Drug: SZ003 CAR-NK In the escalation study, the minimum initial dose was 5.0×10\^6 cells, then increased to 1.0×10\^8 ,2.0×10\^8 and5.0×10\^8 cells. The infusion is given every 2 weeks.

06

What researchers measure

Primary outcomes

  1. The incidence rates and severity of AEs

    To evaluate the safety of SZ003 CAR-NK Cells

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. overall survival (OS)

    To determine the anti-tumor effectivity of SZ003 CAR-NK Cells

    Time frame: up to 2 years

  2. progression-free survival (PFS)

    To determine the anti-tumor effectivity of SZ003 CAR-NK Cells

    Time frame: up to 2 years

  3. disease control rate (DCR) and objective response rate (ORR)

    To determine the anti-tumor effectivity of SZ003 CAR-NK Cells

    Time frame: up to 2 years

  4. duration of response (DOR)

    To determine the anti-tumor effectivity of SZ003 CAR-NK Cells

    Time frame: up to 2 years

07

Study locations

1 site
  • Shantou University Medical College
    Shantou, Guangdong, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in Sep 2024, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2023
First posted
May 6, 2023
StartActual
Jul 26, 2021
Primary completionActual
Sep 30, 2024
CompletionActual
Sep 30, 2024
Last update
Jan 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05845502
Lead sponsor
Shantou University Medical College
Collaborators
Guangdong ProCapZoom Biosciences Co., Ltd.
Responsible party
Yao KaiTao (Deputy Director, Shantou University Medical College) — Principal investigator
First posted
May 6, 2023
Start date
Jul 26, 2021
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024
Last update
Jan 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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