A Single-arm Study of the Efficacy of Tislelizumab Combined With Lenvatinib in Patients With Stage III-IV Renal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab Lenvatinib
- Conditions
- Advanced Kidney Cancer
- Sponsor
- Tianjin Medical University Second Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- PFS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors
- •Previous or concurrent other malignancy
- •Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1
- •History of primary immunodeficiency
- •Active, known or suspected autoimmune diseases
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Pregnant or lactating female patients;
- •Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
- •Have a clear history of active tuberculosis;
- •Participating in other clinical researchers;
Arms & Interventions
Advanced Renal Cell
Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day
Intervention: Tislelizumab Lenvatinib
Outcomes
Primary Outcomes
PFS
Time Frame: assessed up to 4 years
Duration from patient enrollment to disease progression
DCR
Time Frame: assessed up to 4 years
PerPercentage of evaluable cases in which patients were in remission or stable after treatmen