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A total of 92 subjects with advanced melanoma who met the inclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group and the control group in this phase II trial. The study will be followed up until 24 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM103 TILs Group | Experimental |
| |
| Chemotherapy Group | Active Comparator | Chemotherapy regimen selected by investigators |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM103 TILs Injection | Biological | Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS confirmed by the Independent Review Committee (IRC) according to RECIST 1.1 | Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS and OS rates in 6, 12, 18, 24 months | Maximum 24 months |
| PFS | PFS confirmed by the investigators according to RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, Prof. Dr. Med | Contact | 86-10-88121122 | guoj307@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Go Broad Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D000077204 | Temozolomide |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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| Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin | Drug | The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin. |
|
| Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months |
| Objective Response Rate (ORR) | ORR assessed by IRC and investigators according to RECIST 1.1 | Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months |
| Disease Control Rates (DCR) | DCR assessed by IRC and investigators according to RECIST 1.1 | Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months |
| Duration of Response (DoR) | DoR assessed by IRC and investigators according to RECIST 1.1 | Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months |
| Adverse Events (AEs) | AEs will be recorded and assessed according to CTCAE Version 5.0 | Maximum 24 months |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
|
| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
|
| The Third People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |