Actively Recruiting
Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Led by Beijing 302 Hospital · Updated on 2024-08-13
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
CONDITIONS
Official Title
Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Diagnosis of hepatocellular carcinoma with BCLC stage B or C
- Expected survival time longer than 3 months
- Liver function grade Child-Pugh A or B without hepatic encephalopathy
- Left ventricular ejection fraction (LVEF) of 50% or higher
- ECOG physical status score of 0 to 2
- Baseline laboratory tests meeting: Absolute neutrophil count >1.0 x 10^9/L; White blood cell count >2.0 x 10^9/L; Platelet count >60 x 10^9/L; Hemoglobin >8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal; Serum total bilirubin ≤ 51 mmol/L or less than 3 times the upper limit of normal
- Female participants of childbearing potential must use effective birth control and have a negative pregnancy test within 48 hours before treatment
- Ability to receive treatment and follow-up at the enrollment center
You will not qualify if you...
- Pregnant or breastfeeding women
- HIV/AIDS infection
- Active infection with temperature >38.3°C before treatment or antibiotic use within 2 weeks prior to enrollment
- Severe autoimmune disease requiring prolonged immunosuppression or symptomatic immune-mediated disease
- Autoimmune-induced motor neuron disease
- Prior toxic epidermal necrolysis
- Psychiatric conditions including dementia or altered mental status interfering with study participation
- Other cancers diagnosed within the past 5 years
- Heart failure grade 2 or higher (NYHA) or uncontrolled hypertension
- Unstable or active peptic ulcer or gastrointestinal bleeding
- Serious uncontrollable disease interfering with study treatment
- Current treatment with systemic steroids
- Immune cell therapy within 28 days before screening
- Allergy to cell therapy products or related drugs
- Previous or planned organ transplant
- Need for anticoagulant therapy (warfarin or heparin)
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the Fifth Medical Center of PLA
Beijing, China
Actively Recruiting
Research Team
J
Junliang Fu, PhD, MD
CONTACT
F
Fu-Sheng Wang, PhD, MD
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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