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Slow enrollment
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The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-TIL and Tislelizumab | Experimental | L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (ORR) | The objective response rate (ORR) at 8 weeks from baseline. | 8 weeks |
| Efficacy (ORR) | The objective response rate (ORR) at 16 weeks. | 16 weeks |
| Efficacy (DOR) | The duration of response (DOR) at 1-year. | 1 year |
| Efficacy (DOR) | The duration of response (DOR) at 2-year. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | The PFS rate at 1 year. | 1 year |
| Progression free survival (PFS) | The PFS rate at 2-year. | 2 years |
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Inclusion Criteria:
1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.
8. Other tumor disease.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quanli Gao, Ph.D | Henan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408117 | Background | Li T, Zhao L, Yang Y, Wang Y, Zhang Y, Guo J, Chen G, Qin P, Xu B, Ma B, Zhang F, Shang Y, Li Q, Zhang K, Yuan D, Feng C, Ma Y, Liu Z, Tian Z, Li H, Wang S, Gao Q. T Cells Expanded from PD-1+ Peripheral Blood Lymphocytes Share More Clones with Paired Tumor-Infiltrating Lymphocytes. Cancer Res. 2021 Apr 15;81(8):2184-2194. doi: 10.1158/0008-5472.CAN-20-2300. Epub 2021 Jan 6. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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L-TIL and Tislelizumab
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| Overall survival (OS) | The OS rate at 1 year. | 1 year |
| Overall survival (OS) | The OS rate at 2-year. | 2 years |
| Safety (adverse events) | The adverse events followed by treatment. | 2 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |