Pembrolizumab Plus Lenvatinib in Stage III-IV RCC

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • 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 Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery.

Description

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation.Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery. The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.

Details
Condition Advanced Kidney Cancer
Treatment Pembrolizumab plus Lenvatinib
Clinical Study IdentifierNCT05485896
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 and age ≤75years
Patients with pathologically and radiographically confirmed renal cell carcinoma: Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage)
Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery
There are no suspected brain metastases
The presence of measurable lesions was assessed according to RECISTv1.1 criteria
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 >=
x10^9/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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