Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sichuan University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Hunan Cancer Hospital | OTHER |
| West China Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN- Y combined with T cells | Experimental | First, IFN-γ was combined with CIK cells. After three failed treatments, the CIK cells were replaced with T cells. After three failed treatments, CART cells were finally replaced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFN-γ and CIK cells, Tcm cells or CAR T cells | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Puncture-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 | Focusing on the time from the end of the T Cells treatment procedure to the next required drainage or death |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | Proportion of patients who had a best response rating of complete response, partial response, or stable disease | The tumor shrinks or stabilizes for a certain period of time,Lasts at least 4 weeks |
| Objective response rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liu quan, doctor | Contact | 15995299079 | Quanliu.lq@outlook.com | |
| jiang li qing, postgraduate | Contact | 15261479578 | jjiangliq@163.com |
| Name | Affiliation | Role |
|---|---|---|
| quan liu, doctor | Affiliated Hospital of Jiangnan University | Principal Investigator |
| liu quan, doctor | Affiliated Hospital of Jiangnan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Recruiting | Wuxi | Jiangsu | 214000 | China |
The associated efficacy is uncertain
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
Not provided
Not provided
| OTHER |
| Wuxi People's Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Total response and partial response ratio
| 8 weeks |
| Molecular markers for efficacy prediction | Prediction effect | 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 | 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 | From time of treatment to time of disease progression or death from any cause as assessed by the investigator at each treatment period |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |