A randomized controlled trial of autologous cytokine-induced killer cell immunotherapy to prevent recurrence for hepatocellular carcinoma patients after the radical resection.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002093

Enrollment

Unknown

Registered

2012-04-01

Start date

2012-03-20

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Recurrence for hepatocellular carcinoma patients after the radical resection.

Interventions

A:Hepatectomy

B:Hepatectomy combined with CIK cell immunotherapy: CIK cells preparation and reinfusion (a month after hepatectomy) (1) d1 and d6, respectively, to take blood 60ml, isolated peripheral blood mononucl

(2) in vitro by a variety of cytokines (CD3McAb, IL-2, INF-garma and IL-1alpha) were cultured 14-21 days, so that the number of CIK cells for each treatment to 1*1010

(3) CIK cells after autologous peripheral intravenous transfusion

(4) each patient with autologous CIK cell transfusion

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Primary hepatocellular carcinoma by means of postoperative pathology; 2. Technically radical tumor excision; 3. The tumor should be resected completely confirmed by pathological examination; 4. In 14 days before inclusion, liver and kidney function should meet: total bilirubin <=2 mg/dL, ALT and AST <=5 times the normal limits, serum creatinine <=1.5 times normal upper limit value; 6. Aged 20-80 years old,either sex; 7. Without serious mental illness and no serious heart, liver, kidney, pulmonary insufficiency, no other fatal diseases; 8. Voluntary subjects, signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Recurrent hepatocellular carcinoma; 2. With extrahepatic metastasis or lymph nodes; 3. Chemotherapy or interventional therapy or any other adjunctive therapy after operation; 4. Patients complicated with diabetes mellitus or heart diseases or any other organ diseases, can't tolerate the surgery; 5. Now, the recent (-4 weeks, 1 day before) or will join another clinical drug trial research; 6. Patients pregnant or lactating women; 7. The researchers believe that other circumstances can not be selected: the impact into the group of patients to participate in or completion of clinical studies (such as mental illness, substance abuse, HIV infection, etc.); or affect the results of the analysis of clinical studies.

Design outcomes

Primary

Measure	Time frame
Disease free survival;Time to local recurrence;Overall survival rat;	—

Secondary

Measure	Time frame
Biochemical indices of liver function;	—

Countries

China

Contacts

Public ContactFeng Xia

frankfxia@gmail.com+86 023 68765797

Outcome results

None listed

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