The purpose of this study was to evaluate the efficacy of IFN- Y combined with T cells in the treatment of refractory malignant pleural effusion and acties, using a multicenter, single-arm, open design.
Malignant pleural effusion is a common complication of malignant tumor, which usually indicates that the patient has reached the advanced stage, and about 30-40% of the patients are stubborn and refractory cases. The lack of standard therapeutic drugs and protocols in clinical practice seriously affects the anti-tumor treatment effect, quality of life and survival time of patients, and the prognosis is poor. IFN-γ can significantly induce the high expression of the costimulatory molecule ICAM-1 on tumor cells, thereby enhancing the killing of TUMOR cells by T cells. Moreover, IFN-γ can enhance the activity of CAR T cells in the presence of PD-L1-PD-1 pathway, and significantly improve the therapeutic effect of T cells on solid tumors. IFN-γ is an approved clinical treatment with known side effects and well-established symptomatic treatment. Although CIK is not a clinically approved drug, it has been used on a large scale in China with good safety and has entered the medical insurance of some provinces and cities. Tcm is an improved CIK cell and has good safety. Many clinical studies have been carried out, and no serious toxic and side effects have been observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A 50ng/ mL IFN-γ solution was prepared, and the required volume of IFN-γ solution was calculated according to the final concentration of 5ng/ mL according to the volume of pleural fluid or ascites of the patient. CIK cells were injected 1.0-2.0×109 on the second day and review three days later.T cells and CAR T cells were selected sequentially according to the re-examination of pleural fluid or ascites.
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
RECRUITINGPuncture-free Survival (PuFS)
Puncture-free Survival (PuFS) is a clinical endpoint used to measure the time duration during which a patient with a condition like malignant ascites or malignant pleural effusion remains free from needing a puncture procedure
Time frame: Focusing on the time from the end of the T Cells treatment procedure to the next required drainage or death
Disease control rate
Proportion of patients who had a best response rating of complete response, partial response, or stable disease
Time frame: The tumor shrinks or stabilizes for a certain period of time,Lasts at least 4 weeks
Objective response rate
Total response and partial response ratio
Time frame: 8 weeks
Molecular markers for efficacy prediction
Prediction effect
Time frame: 8 weeks
Overall survival
The last follow-up time of the lost patient; Patients who were still alive at the end of the study were at the end of follow-up
Time frame: From the time of diagnosis of tumor to death from any cause,From initiation of study treatment until date of death from any cause, up to 100 months
Progression-free survival
From time of treatment to time of disease progression or death
Time frame: From time of treatment to time of disease progression or death from any cause as assessed by the investigator at each treatment period
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