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This is a phase II study to determine the efficacy and safety of Tislelizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects
This is a phase II study to determine the efficacy and safety of Tislelizumab when given in combination with lenvatinib as treatment for patients with the advanced kidney cancer . Patients will receive treatment with Tislelizumab in combination with lenvatinib every 3 weeks unitl tumor progression or serious side effects.The primary outcome measure was PFS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Renal Cell | Experimental | Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab Lenvatinib | Drug | Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Duration from patient enrollment to disease progression | assessed up to 4 years |
| DCR | PerPercentage of evaluable cases in which patients were in remission or stable after treatmen | assessed up to 4 years |
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Inclusion Criteria:
Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=1.5 ULN
Exclusion Criteria:
HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); Patients with active bleeding or new thrombotic disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changyi Quan, MD,PhD | Contact | 13388067990 | 345920147@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Changyi Quan, MD,PhD | Tianjin Medical University Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changyi Quan | Recruiting | Tianjin | Tianjin Municipality | 300211 | China |
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