A Single-arm Study of the Efficacy of Tislelizumab Combined With Lenvatinib in Patients With Stage III-IV Renal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing and able to provide written informed consent

• Age ≥ 18 years

• Subjects with pathologically and radiologically confirmed renal cell carcinoma: Stage III/IV

• There are no suspected brain metastases

• There are lesions that can be measured by imaging

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

• Organ function level must meet the following requirements:

⁃ 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

• Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study

• The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up

Locations
Other Locations
China
Changyi Quan
RECRUITING
Tianjin
Contact Information
Primary
Changyi Quan, MD,PhD
345920147@qq.com
13388067990
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Advanced Renal Cell
Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Second Hospital

This content was sourced from clinicaltrials.gov

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