Actively Recruiting
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer
Led by Zhiyong Huang · Updated on 2025-08-19
16
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
Sponsors
Z
Zhiyong Huang
Lead Sponsor
W
Wuhan Elongevity Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single-arm, open-label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative(NMA) lymphodepletion preparative regimen for the treatment of patients with advanced liver cancer.
CONDITIONS
Official Title
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent after being informed about the study
- Age between 18 and 70 years
- Histologically confirmed advanced liver cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Confirmed metastatic lesions by imaging or exploration with at least one accessible metastasis for TIL collection
- At least one additional measurable tumor lesion per RECIST 1.1 criteria
- Disease progressed after at least two previous standard treatments with no effective options remaining
- Adequate organ and marrow function including specific blood count and liver and kidney function limits
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before cell reinfusion
- Able to provide at least one gram of fresh tumor tissue and 10ml peripheral blood for analysis
- Expected survival of at least 3 months
- Child-Pugh liver function grade A within 7 days before cell reinfusion
You will not qualify if you...
- Presence of other active cancers except cured carcinoma in situ without recurrence in 5 years or curable cancers
- Metastasis to central nervous system or brain
- History of organ transplantation
- Major liver surgery within 4 weeks before first treatment (except biopsy)
- Local liver or other treatments within 4 weeks before first treatment including TACE, TAE, HAI, radiotherapy, radioembolization, or ablation
- Severe arterial embolism or hepatic artery vascular variation after CT angiography
- Coagulation disorders or bleeding history within 2 months
- Active infection or inflammation within 7 days after antibiotics
- Major surgery or severe trauma within 4 weeks before enrollment
- Active or unstable heart conditions including recent angina or myocardial infarction within 12 months
- Recent thrombosis or embolism events within 12 months
- Congestive heart failure NYHA class II or higher
- HIV infection or AIDS, untreated active hepatitis B or C, or co-infection
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Interstitial lung disease or uncontrolled systemic diseases
- Previous treatment side effects of grade 2 or higher except anemia, hair loss, or skin pigmentation
- Pregnant or breastfeeding women or positive pregnancy test before first injection
- Clinical or laboratory abnormalities or compliance issues deemed unsuitable by investigator
- Serious psychological or mental disorders
- Participation in other clinical trials within 4 weeks
- History of hypersensitivity to cyclophosphamide or fludarabine
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, China, 430000
Actively Recruiting
Research Team
T
Tong Yuan
CONTACT
T
Tian Xia
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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