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Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer

ConditionLiver Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhiyong Huang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Tumor Infiltrating Lymphocytes

    Biological/Vaccine

    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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Treatment (autologous tumor infiltrating lymphocytes)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
Up to 24 months
3

Maximum tolerated dose [Safety and Tolerability]

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

Time frame
1 month

Secondary outcomes

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).

Time frame
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).

Time frame
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).

Time frame
Up to 24 months
4

Overall Survival (OS)

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

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhiyong Huang

Lead sponsor

Tongji Hospital

Sponsor institution

Wuhan Elongevity Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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