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This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment.
Biopsy is needed to exclude patients with positive allograft PD-L1 expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | JS001(PD-1 inhibitor), 240mg I.V. Q3W, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS001(PD-1 inhibitor) | Drug | 240mg I.V. Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Event Rate | the occurrence rate of serious adverse event after PD-1 inhibitor treatment | 1.5 years |
| Acute Graft Rejection Rate | the occurrence rate of acute graft rejection after PD-1 inhibitor treatment | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate after PD-1 inhibitor treatment | 3 years |
| Progression Free Survival Rate | survival time after PD-1 inhibitor treatment till tumor progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowu Huang, M.D. | Contact | +86-13701811021 | huang.xiaowu@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 3 years |
| Over all survival Rate | survival time after PD-1 inhibitor treatment till patient death | 3 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |