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

Primary Purpose

Advanced Kidney Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab Lenvatinib
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Kidney Cancer focused on measuring Tislelizumab Lenvatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changyi QuanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Advanced Renal Cell

Arm Description

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

Outcomes

Primary Outcome Measures

PFS
Duration from patient enrollment to disease progression
DCR
PerPercentage of evaluable cases in which patients were in remission or stable after treatmen

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
August 4, 2022
Sponsor
Tianjin Medical University Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05485883
Brief Title
Tislelizumab Plus Lenvatinib in Stage III-IV RCC
Acronym
TILUR
Official Title
A Single-arm Study of the Efficacy of Tislelizumab Combined With Lenvatinib in Patients With Stage III-IV Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Kidney Cancer
Keywords
Tislelizumab Lenvatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Renal Cell
Arm Type
Experimental
Arm Description
Patients will receive treatment with Tislelizumab every 3 weeks,and take Lenvatinib 8mg every day
Intervention Type
Drug
Intervention Name(s)
Tislelizumab Lenvatinib
Intervention Description
Patients will receive treatment with Tislelizumab in combination with Lenvatinib every 3 weeks unitl tumor progression or serious side effects
Primary Outcome Measure Information:
Title
PFS
Description
Duration from patient enrollment to disease progression
Time Frame
assessed up to 4 years
Title
DCR
Description
PerPercentage of evaluable cases in which patients were in remission or stable after treatmen
Time Frame
assessed up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changyi Quan, MD,PhD
Phone
13388067990
Email
345920147@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changyi Quan, MD,PhD
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changyi Quan
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changyi Quan, PhD
Phone
13388067990
Email
345920147@qq.com

12. IPD Sharing Statement

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Tislelizumab Plus Lenvatinib in Stage III-IV RCC

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