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A randomized controlled study for autologous NK cell immunotherapy for hepacytocellular carcinoma.

A randomized controlled study for autologous NK cell immunotherapy for hepacytocellular carcinoma.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022052
Enrollment
Unknown
Registered
2019-03-22
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic carcinoma

Interventions

NK cell immunothepy after hepatectomy group:NK cell and hepatectomy
hepatectomy group :hepatectomy group
NK cell combined with Minimally invasive treatment group:NK cell combined with Minimally invasive treatment group
Minimally invasive treatment group:Minimally invasive treatment
NK cell+Advanced liver cancer group:NK cell
Advanced liver cancer group:conventional therapy

Sponsors

Mengchao Hepatobiliary Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 80 years old, No gender limitation; 2.Primary hepacytocellular carcinoma were certained by clinical detection,without distal metastasis(those who will be inclusion the group of advanced cancer was not limitted) 3.There should be at least one measurable tumor indicator. 4.No suffering from other tumor. 5.The score of Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 6.The survival of patients should longer than 3 months, and accept follow-up visit. 7. The hematopoietic function of bone marrow should be normal:White blood cell(WBC) > 4.0×10^9/L,platelet (PLT)> 100×10^9/L,neutrophilic granulocyte(ANC)= 1.5×109/L,hemoglobin(HGB) = 90g/L,aspartic transaminase hemoglobin =2.5×upper normal limit(UNL),alanine aminotransferase=2.5×UNL,total bilirubin(TBil) =1.5×UNL,serum creatinine=1.0×UNL, prothrombin time,partial thromboplastin time,Plasma fibrinogen and thrombin time were normal; 8. All the patients volunteer should rule out pregnancy until the follow-up completed. 9. The patients volunteer to join in the trial and sign the informed consents.

Exclusion criteria

Exclusion criteria: 1. Clinical symptoms of metastasis should be exclucive,the group of advanced cancer was not limitted. 2. Activing viral or bacterial infections cannot be controlled with appropriate anti-infective therapy should be exclucive. Except HBV patients. 3. Patients with mental illness or other conditions, such as uncontrollable heart or lung disease, diabetes, etc., or the patients cannot cooperate with the researchers for treatment and monitoring requirements. 4. Active rheumatic disease. 5. Organ transplant. 6. Pregnant or lactating women; Disabilitie persons sprescribed by law (such as:blind, deaf, dumb, mentally retarded, physically disabled) or suffering from mental diseases; Taking drugs or adverse drug abuse and alcohol dependence within 5 years are exclucive also. 7. Participating in or participating in other clinical trials within 1 month; 8. The investigator determines that any factors that the patients are not suitable for the study.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
QOL;security;

Countries

China

Contacts

Public ContactXiaolou Li
lixiaolou2014@163.com+86 13405906054

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026