Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer

Recruiting now · Phase 1

Conditions studied: Liver Cancer

In brief

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.

Key facts

Study ID

NCT06084299

Run by

Zhiyong Huang

People needed

16

Starts

2020-05-27

Expected to finish

2026-08-30

Last updated by the study team

2025-08-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subjects must be informed of the study before the test and voluntarily sign a written informed consent.
• Age of the patients was between 18\~70 years
• Eligible patients have histologically proven advanced liver cancer
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-1
• Metastatic lesions are confirmed by PET-CT, CT, MR and/or intraoperative exploration (more than 3, at least one accessible metastasis to procure for TILs)
• Patients have at least one separate additional measurable tumour lesion according to RECIST version 1.1 standard.
• The disease has progressed after at least two previous lines of standard treatment and there is no effective treatment option available
• Adequate normal organ and marrow function were present, including absolute neutrophil count ≥ 1×10\^9/L, leukocyte count ≥ 3×10\^9/L, platelet count ≥ 75×10\^9/L, hemoglobin ≥ 80 g/L, AST and ALT ≤ 2× of upper limit of normal, Serum creatinine ≤ 1.5× upper normal limits, Serum total bilirubin ≤ 1.5× upper normal limits
• Female subjects of childbearing age must have a negative urine or serum HCG test within 7 days before cell reinfusion
• Provide at least one gram of fresh tumor tissue and 10ml of peripheral blood for whole exome sequencing and TIL isolation and culture.
• Expected survival was at least 3 months
• Child-Push liver function score grade is A within seven days before the cell reinfusion.

You may not qualify if…

• With previous or concurrent other active cancer (except carcinoma in situ that has been cured without onset within 5 years, or those that can be cured by adequate treatment)
• Patients with metastasis to Central Nervous System or brain
• Have received organ transplantation in the past
• Received major liver surgery within 4 weeks before the first administration (except liver metastases biopsy).
• Received local treatment of the liver or other parts within 4 weeks before the first administration (transcatheter arterial chemoembolization [TACE], transcatheter arterial embolization [TAE], hepatic artery infusion [HAI], radiotherapy, radioembolization or ablation). Subjects are not eligible to participate in the study if the above-mentioned treatment is carried out between the last dose of sorafenib or oxaliplatin-containing regimen and the first study administration.
• After CT angiography examination, there is severe arterial embolism or hepatic artery vascular variation.
• APTT or PT >= 5 UNL, or with bleeding evidence in two months or bleeding history in prior to the clinical study, no matter how serious it is
• Active inflammation within 7 days after systemic antibiotics treatment
• Subjects who have undergone major surgery or severe trauma such as laparotomy, thoracotomy, and laparoscopic organ removal within 4 weeks before enrollment.
• Active coronary artery disease, serious or unstable angina pectoris, or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to the clinical study
• Thrombosis or embolism event within 12 months prior to the clinical study, such as cerebrovascular accident ( including TIA) or pulmonary embolism
• Congestive heart failure of NYHA >= Class II
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml C Hepatitis, defined as HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C.
• Presence of any active, known or suspected autoimmune disease. Subjects in a stable state who do not require systemic immunosuppressive therapy are allowed, such as: type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases that do not require systemic therapy (e.g., vitiligo, psoriasis disease and hair loss).
• Any interstitial lung disease, noninfectious causes of lung inflammation, or uncontrolled systemic disease (e.g. diabetes, pulmonary fibrosis, or acute pneumonia)
• Any adverse event of CTCAE (Ver 5.0) grade 2 or higher induced by previous treatment, except anemia, hair loss, and skin pigmentation
• Pregnant or lactating women or those who are positive in pregnancy test before 1st injection
• The investigator believes that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable for participating in this clinical study.
• With serious psychological or mental abnormalities
• Joined other clinical trials in four weeks prior to this study
• Patients who have a history of hypersensitivity to cyclophosphamide and fludarabine.
• Other researchers think that they are not suitable for enrollment.

Where it is running

• Tongji Hospital — Wuhan, China (enrolling)

Full record on ClinicalTrials.gov

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