Tislelizumab Plus Lenvatinib in Stage III-IV RCC (TILUR)

Tianjin Medical University Second Hospital

Status and phase

Enrolling

Phase 2

Conditions

Advanced Kidney Cancer

Treatments

Drug: Tislelizumab Lenvatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05485883

TILUR

Details and patient eligibility

About

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

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;
Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
Uncontrolled concurrent diseases, including but not limited to:

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