Actively Recruiting
Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2025-08-14
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this open-label, single-arm phase I/II clinical trial is to evaluate the feasibility, safety, and anti-tumor efficacy of the autologous neoantigen-specific T-cell therapy (iNeo-Vac-T01) in patients with advanced hepatocellular carcinoma who have failed second-line or later systemic therapies.
CONDITIONS
Official Title
Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive)
- Histologically confirmed advanced hepatocellular carcinoma (HCC) with radiologically measurable disease per RECIST v1.1
- Documented progression on two or more prior lines of systemic therapy
- Life expectancy of at least 6 months
- ECOG performance status of 0 or 1
- Available archival or fresh tumor tissue sufficient for comprehensive genomic profiling OR existing genomic sequencing data meeting quality standards
- Adequate organ and marrow function including specific blood counts and liver, kidney, and coagulation parameters
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment and agree to use effective contraception during the study and for 120 days after last intervention
- Men must agree to use barrier contraception during the study and for 120 days after last intervention
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and study procedures
You will not qualify if you...
- History of other active cancers within 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancers considered cured with minimal recurrence risk
- Unable to identify therapeutically targetable neoantigens via genomic analysis
- Prior allogeneic bone marrow, solid organ, or stem cell transplant
- Active or symptomatic central nervous system metastases except stable treated CNS metastases for at least 4 weeks and off corticosteroid/anticonvulsant therapy for at least 4 weeks; leptomeningeal disease is excluded
- Active bacterial, fungal, or mycobacterial infections requiring systemic therapy, including untreated latent tuberculosis
- Active viral infections such as detectable hepatitis B DNA, hepatitis C RNA, HIV infection, or active syphilis
- Active autoimmune disease requiring systemic immunosuppressive therapy greater than 10 mg prednisone equivalent daily within past 2 years except specific stable conditions
- Systemic immunosuppressive therapy greater than 10 mg prednisone equivalent daily within 14 days before planned cell infusion
- Uncontrolled illness including severe heart failure, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, or significant pulmonary disease
- History of substance abuse or psychiatric/social conditions impairing consent or study compliance
- History of severe hypersensitivity reactions to vaccine components or investigational products
- Any condition deemed by the investigator to pose unacceptable risk or interfere with study participation or results interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Tingbo Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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