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Lymphoepithelioma-like carcinoma (LELC) may benefit from immunocheckpoint inhibitor therapy. Although target antibody drugs for PD-1 and PD-L1 have achieved good results in immunotherapy of many malignant tumors, there is still a lack of corresponding clinical research reports on whether LELC treatment can benefit. Therefore, this study intends to adopt the basket research model , to explore the application of anti-procedural death receptor 1 (PD-1) monoclonal antibody in patients with advanced LELC after the failure of first-line standard treatment . Further explore the relationship between tumor and body immunity, tumor microenvironment and curative effect, and find stable biomarkers, so as to screen out the superior population of tumor immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 monoclonal antibody | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 monoclonal antibody | Drug | 200mg / intravenous drip, once every three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | The time from enrollment to the occurrence of tumor development (in any aspect) or death (for any reason). For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. Subjects who did not undergo imaging evaluation or no death record after baseline were deleted based on the enrollment date. | Through study completion, an average of 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | According to the RECIST 1.1 standard, the proportion of subjects with complete response(CR) or partial response(PR) in the analysis population. | Through study completion,an average of 9 weeks |
| Time to initial response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lirong Liu, MM | Contact | 86 20 81887233 | 34830 | doctorllr@163.com |
| Zhenzhen Xiao, MM | Contact | 86 20 81887233 | 34830 | 768197690@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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The time from enrollment to the first objective response (CR or PR) of the tumor.
For subjects who did not reach CR or PR, the date of the last imaging evaluation was the date of censorship.
| Through study completion,an average of 9 weeks |
| Overall survival | The time from enrollment to (for any reason) death. At the end of the study, if the subject is still alive, the known date of the subject's last survival" will be the censored date. | Through study completion, an average of 90 days |
| Duration of response | The time from the first recorded objective tumor response (CR or PR) to objective disease progression (PD) or death. For subjects without disease progression or death, the date of the last imaging evaluation is the date of censorship. | Through study completion,an average of 9 weeks |
| Tumor immune microenvironment | immune microenvironment state of tumor tissue will be detected by Opal multiplex immunofluorescence assay | Baseline |