Immunotherapy using tumor-infiltrating lymphocytes for advanced liver cancer
Official title: Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer
Run by Tongji Hospital · NCT06084299 · Data updated 2026-11-12
This study is testing a new treatment using patients' own immune cells to see if it can help people with advanced liver cancer who haven't had success with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 1 site (Wuhan) |
| Status | Recruiting |
| Started | May 27, 2020 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT06084299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with histologically confirmed advanced liver cancer who have experienced disease progression after at least two prior treatments.
✕Probably not a fit
Patients with early-stage liver cancer or those who have not undergone previous treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of adoptive cell therapy using autologous tumor-infiltrating lymphocytes (TIL) for patients with advanced liver cancer. Participants will undergo a non-myeloablative lymphodepletion preparative regimen followed by intravenous infusion of their own TILs, along with interleukin-2 (IL-2) treatment. The goal is to assess the safety and efficacy of this innovative approach in patients who have not responded to standard treatments.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced liver cancer who have limited effective therapies available.
How similar studies have gone: Other studies using adoptive cell therapy for various cancers have shown promising results, suggesting potential success for this approach in liver cancer as well.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
Tongji Hospital
Wuhan, China Recruiting
Study contacts
- Principal investigator: Zhiyong Huang — Tongji Hospital
- Study coordinator: Tong Yuan
- Email: Zyhuang126@126.com
- Phone: 86-15071338542
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.