Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Administered via hepatic arterial infusion (HAI)
Administered via isolated hepatic perfusion
low-dose, administered s.c.
Incidence and severity of adverse events
Graded according to Common Terminology Criteria for Adverse Events version 5.0
Time frame: 5 years
Objective response rate
Defined as the proportion of patients with a best overall response of partial response or better defined by RECIST 1.1
Time frame: 5 years
Progression-free survival
Defined as the time from inclusion to objective tumor progression (determined by RECIST 1.1), or death due to any cause, whichever occurred first.
Time frame: 5 years
hepatic Progression-free survival
Defined as the time from inclusion to objective tumor progression in the liver (determined by RECIST 1.1), or death due to any cause, whichever occurred first.
Time frame: 5 years
Duration of response
Defined as the time from the first documented response and the date of the first documented tumor progression, death, or the last tumor assessment that occurred before subsequent therapy.
Time frame: 5 years
Overall survival
Defined as the time from inclusion to the date of death due to any cause
Time frame: 5 years
Evaluation of Tolerability
Defined as the proportion of patients included that receive PHP and TIL
Time frame: 5 years
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