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RecruitingNCT05485883TILURUpdated Aug 8, 2022

Tislelizumab Plus Lenvatinib in Stage III-IV RCC

A Phase 2 interventional study of Tislelizumab Lenvatinib in Advanced Kidney Cancer, sponsored by Tianjin Medical University Second Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Advanced Kidney Cancer

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Keywords

  • Tislelizumab Lenvatinib
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 20 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Advanced Renal Cell

    Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day

    Drug: Tislelizumab Lenvatinib

Interventions

  • DrugTislelizumab Lenvatinib

    Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects

06

What researchers measure

Primary outcomes

  1. PFS

    Duration from patient enrollment to disease progression

    Time frame: assessed up to 4 years

  2. DCR

    PerPercentage of evaluable cases in which patients were in remission or stable after treatmen

    Time frame: assessed up to 4 years

07

Study locations

1 of 1 sites recruiting
  • Changyi Quan
    Tianjin, Tianjin 300211, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05485883
Lead sponsor
Tianjin Medical University Second Hospital
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Jul 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 8, 2022

Study contacts

Changyi Quan, MD,PhD
Contact
345920147@qq.com
13388067990
Changyi Quan, MD,PhD
principal investigator · Tianjin Medical University Second Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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