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Safety and Efficacy of Autoimmune Cell Therapy for Patients with Hepatocellular Carcinoma

Safety and Efficacy of Autoimmune Cell Therapy for Patients with Hepatocellular Carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052660
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-12-31
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

Hepatocellular Carcinoma

Interventions

Experimental group:IPM001 injection

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Understand and voluntarily sign the informed consent; 2. Aged 18 to 75 years, male or female; 3. Patients with primary hepatocellular carcinoma; 4. According to the National Health and Family Planning Commission of the People's Republic of China for the diagnosis and treatment of primary liver cancer (2017 edition) clinical staging of liver cancer (see Appendix 1), patients with stage Ia ~ IIIa; 5. Child-Pugh score =1 peptide library Neoantigen or >=2 peptide library aeTSA; 7. ECOG PS score is 0~2 points; 8. No major organ dysfunction (laboratory examination): (1) White blood cell count >= 3.0 x 10^9/L; (2) Neutrophils >= 1.5 x 10^9/L; (3) Hemoglobin >= 85g/L; (4) Platelet count >= 5 x 10^10/L; (5) Total bilirubin = 3.0 g/dL (30 g/L); (8) Serum creatinine 50 kg, female > 45 kg; 10. No obvious genetic disease; 11. Expected survival >= 6 months.

Exclusion criteria

Exclusion criteria: 1. Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.; 2. Woman be pregnant or lactating; 3. Suffer from mental or neurological diseases that are resistant to control; 4. The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.) 5. Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis); 6. Patients with a history of other malignant tumors in the past 5 years; 7. Organ transplantation or Myelosuppression; 8. History of drug abuse or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;

Secondary

MeasureTime frame
Overall survival;Quality of Life;

Countries

China

Contacts

Public ContactZhang Hao

Huashan Hospital Affiliated to Fudan University

drhao@hotmail.com+86 21 52887165

Outcome results

None listed

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