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Study on the combination of interferon and multi-signal loaded dendritic cells superimposed conditional cyclophosphamide immunotherapy to reduce the recurrence rate of hepatitis B associated hepatocellular carcinoma after resection

Basic and Applied Basic Research project

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040749
Enrollment
Unknown
Registered
2020-12-08
Start date
2020-12-15
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

hepatocellular carcinoma

Interventions

group A:resection combined with immunotherapy (interferon and multi-signal loaded dendritic cells superimposed conditional cyclophosphamide)
group B:only resection

Sponsors

Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. A history of chronic HBV infection; 2. Aged 18-60 years old; 3. Meet the requirements of the American Society for the Study of Liver Diseases (AASLD) guidelines for the diagnosis of hepatocellular carcinoma, i.e. primary hepatocellular carcinoma confirmed by histological or imaging examination; 4. Child-pugh grade A liver function, ICG-R15<30%; 5. The informed consent is signed in person; 6. Staging of primary hepatocellular carcinoma was performed according to the Barcelona (BCLC) liver cancer staging system: STAGE 0 or Stage A1 of BCLC, which was evaluated by two liver surgeons as feasible radical surgery.

Exclusion criteria

Exclusion criteria: (1) Extrahepatic metastasis; (2) Had a history of major surgery 4 weeks ago; (3) Women who have positive pregnancy tests or are lactating; (4) The presence of a second cancer or prior history of other cancers is stable for less than 3 years after treatment; (5) serious and uncontrollable disease of the whole body; Autoimmune diseases; Mental illness or other factors affecting informed consent; (6) HIV infection;Infection with other hepatitis viruses; (7) Blood routine examination: Hb50umol/L, AST or ALT>10 ULN; (9) Immunosuppressive therapy is required for other diseases.

Design outcomes

Primary

MeasureTime frame
1, 2, 3 years disease-free survival (DFS) after surgery;1, 2, 3 years progression-free survival (PFS) after surgery;AFP;

Secondary

MeasureTime frame
blood routine test;

Countries

China

Contacts

Public ContactGu Yurong

Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University

guyr163@163.com+86 18588628204

Outcome results

None listed

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