Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged 18 to 70 years;

• Diagnosis of HCC with BCLC stage B/C;

• Anticipated survival time is longer than 3 months;

• Liver function grade Child-Pugh A or B, without hepatic encephalopathy;

• Left ventricular ejection fraction (LVEF) ≥ 50%;

• ECOG physical status 0-2;

• Laboratory tests at baseline meet the following: Absolute neutrophil count \>1.0 x 109/L; Absolute neutrophil count \>1.0 x 109/L; White blood cell count \> 2.0 x 109/L; Platelet count \> 60 x 109/L; Hgb \> 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or \< 3 times the ULN.

• Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;

• Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.

Locations
Other Locations
China
the Fifth Medical Center of PLA
RECRUITING
Beijing
Contact Information
Primary
Junliang Fu, PhD, MD
fjunliang@163.com
86-10-66933214
Backup
Fu-Sheng Wang, PhD, MD
fswang302@163.com
86-10-66933328
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 20
Treatments
Experimental: Tumor-infiltrating Lymphocytes Therapy
Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0\*10\^7/Kg, single intravenous infusion.
Related Therapeutic Areas
Sponsors
Leads: Beijing 302 Hospital

This content was sourced from clinicaltrials.gov