Clincosm LogoSign in Get a demo

TILUR: Tislelizumab Plus Lenvatinib in Stage III-IV RCC

Sponsor
Tianjin Medical University Second Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05485883
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
42
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Tislelizumab Lenvatinib
 Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm Study of the Efficacy of Tislelizumab Combined With Lenvatinib in Patients With Stage III-IV Renal Cancer
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Advanced Renal Cell

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

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

Outcome Measures

Primary Outcome Measures

  1. PFS [assessed up to 4 years]

    Duration from patient enrollment to disease progression

  2. DCR [assessed up to 4 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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 >= 1.5x109/L, platelet count >= 100x109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changyi Quan Tianjin Tianjin China 300211

Sponsors and Collaborators

  • Tianjin Medical University Second Hospital

Investigators

  • Principal Investigator: Changyi Quan, MD,PhD, Tianjin Medical University Second Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier:
NCT05485883
Other Study ID Numbers:
  • TILUR
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Jul 1, 2022
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
Keywords provided by Tianjin Medical University Second Hospital
Tislelizumab Lenvatinib
Additional relevant MeSH terms:
Kidney Neoplasms
Lenvatinib

Study Results

No Results Posted as of Aug 8, 2022