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Liver CancerPhase 1NCT06084299

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes in people with Liver Cancer, run by Zhiyong Huang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Liver Cancer
What is being tested?
Autologous Tumor Infiltrating Lymphocytes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
27 May 2020to 30 Aug 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tong Yuan contact

86-15071338542

Zyhuang126@126.com

Tian Xia contact

tianxia@hust.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, 430000

    Tong Yuan, 86-15071338542, Zyhuang126@126.com

    Tian Xia, tianxia@hust.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

This is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process for the treatment of patients with advanced liver cancer. The cell transfer therapy used in this study involves patients receiving a non-myeloablative lymphodepletion preparative regimen, followed by i.v. infusion of autologous tumor-infiltrating lymphocytes followed by the administration of a regimen of IL-2.

Conditions
Liver Cancer
Being tested
Autologous Tumor Infiltrating Lymphocytes
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Tumor Infiltrating LymphocytesBiological

    Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation, and extensive expansion.

Study groups in NCT06084299
Study groupRoleWhat they receive
Treatment (autologous tumor infiltrating lymphocytes)ExperimentalPost-NMA lymphodepletion, patients are infused with their autologous TIL followed by IL-2 administration.
Receives: Biological: Autologous Tumor Infiltrating Lymphocytes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Types and incidence of Dose-limiting toxicity (DLT) [Safety and Tolerability]

    Dose-limiting toxicity (DLT) will be collected and graded according to CTCAE v5.0

    Measured: 1 month

  2. Types and incidence of adverse events (AEs) ,serious adverse events (SAEs) [Safety and Tolerability]

    AE will be collected and graded according to CTCAE v5.0

    Measured: Up to 24 months

  3. Maximum tolerated dose [Safety and Tolerability]

    Evaluate the maximum tolerated dose of TILs in patients with advanced liver cancer

    Measured: 1 month

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    PFS will be calculated as the time from TIL infusion to disease progression or death from any cause (whichever occurs first) (RECIST v1.1).

    Measured: 6 months

  2. Disease Control Rate (DCR)

    DCR will be calculated as the percentage of patients who achieved Stable Disease(SD) or better for more than 8 weeks (RECIST v1.1).

    Measured: Up to 24 months

  3. Objective response rate (ORR)

    ORR will be calculated as the percentage of patients who achieved partial response (PR) or better (RECIST v1.1).

    Measured: Up to 24 months

  4. Overall Survival (OS)

    Time from TIL infusion to time of death due to any cause

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start27 May 2020
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084299
Sponsor's protocol ID
YS-TIL-TJL01
Status last verified
Aug 2025
First submitted
3 Oct 2023
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani NI, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022 Dec;10(12):e005755. doi: 10.1136/jitc-2022-005755.

    PubMed 36600653

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes in people with Liver Cancer, run by Zhiyong Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tong Yuan (86-15071338542, Zyhuang126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Types and incidence of Dose-limiting toxicity (DLT) [Safety and Tolerability] (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06084299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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