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A randomized controlled study for Autologous DC-CIK in prevention of recurrence or metastasis of Hepatocellular Carcinoma after hepatectomy.

A randomized controlled study for Autologous DC-CIK in prevention of recurrence or metastasis of Hepatocellular Carcinoma after hepatectomy.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022274
Enrollment
Unknown
Registered
2019-04-02
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-04-08

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

Conditions

Hepatic carcinoma

Interventions

DC-CIK immunotherapy Group:DC-CIK immunotherapy after hepatectomy
hepatectomy group :hepatectomy

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, No gender limitation. 2.To be diagnosed with resectable hepatocellar carcinoma by clinicopathology, and the BCLC stage is A or B. No residual tumor and no metastatic or recurrence tumor were found by CT or MRI scanning after hepatectomy for four weeks. 3.Patients with expected survival more than 6 months. 4.The score of Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; 5.The hematopoietic function of bone marrow should be normal:White blood cell(WBC)> 4.0×10^9/L, platelet (PLT)> 100×10^9/L, hemoglobin (Hb)>120 g/L; 6. Fertile female patients should be excluded from pregnancy, and HCG must be negative;both male and female subjects should Use contraception during the study. 7.The patients volunteer to join in the trial and sign the informed consents.

Exclusion criteria

Exclusion criteria: 1) Combined with other primary malignant tumors; 2) Bone marrow or organ transplantation history; Gastrointestinal bleeding tendency;Coagulation dysfunction; Or thrombotic diseases; 3) Autoimmune deficiency disease;Infection by various virus which do not under control (including HAV, HCV, HDV, etc.); 4) Suffering from other severe systemic diseases, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune and urinary diseases, The factors may interfere with the treatment evaluation and compliance of this study; Or biochemical indicators: serum bilirubin (TBILI) > 1.5 * ULN ( The upper limit of the normal reference values), ALT and AST >2.5*ULN,Serum creatinine (Cr)> 2*ULN. 5) Pregnant or nursing women; Disabilities patients by law (blind, deaf, dumb, mentally retarded, physically disabled) or Mental diseases;Taking drugs or Adverse drug abuse and alcohol dependence within 5 years; 6) Participating in or participated in other clinical trials within one month; 7) The investigator judges that the patient is not fit for this study due to any factors.

Design outcomes

Primary

MeasureTime frame
PFS;OS;

Secondary

MeasureTime frame
QOL;Safety;

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