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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    20
  • sponsor
    Tianjin Medical University Second Hospital
Updated on 4 October 2022

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

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

Details
Condition Advanced Kidney Cancer
Treatment Tislelizumab Lenvatinib
Clinical Study IdentifierNCT05485883
SponsorTianjin Medical University Second Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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