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Neoadjuvant Immune-based Combinations in Patients Undergoing Nephrectomy for Locally Advanced ccRCC

Neoadjuvant Immune-based Combinations in Patients Undergoing Nephrectomy for Locally Advanced ccRCC

Recruiting
18 years and older
All
Phase 2

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Overview

The objective of this single-center clinical trial was to evaluate the objective response rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) in neoadjuvant treatment of(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma.

Description

The objective of this single-center clinical trial was to evaluate the objective response rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) in neoadjuvant treatment of(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma.Toripalimab is a new antibody that may help activate the immune system by blocking the function of the inhibitory molecule PD-1. This is a single-institution, single-arm Phase 2 clinical trial. Patients will be treated with Toripalimab in combination with tyrosine kinase inhibitors TKI (Lenvatinib) and patients will undergo partial or radical nephrectomy after neoadjuvant therapy.

Eligibility

Inclusion Criteria:

  • Imaging is consistent with(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma
  • Puncture pathological biopsy was consistent with clear cell renal cell carcinoma
  • Subjects were to undergo radical nephrectomy or partial nephrectomy or enucleation of renal tumor
  • ECOG 0-1 points -Normal hematopoietic and organ function --
  • Understand and plan visits, treatments, laboratory tests, and other research procedures.

Exclusion Criteria:

  • Prior systemic anti-tumor treatment for RCC
  • Patients who are receiving any other investigational agents.
  • Clinical status indicating that immediate surgery (within 6 weeks) iswarranted regardless of whether neoadjuvant therapy is to beadministered, as assessed by the treating surgeon.
  • Inability to undergo baseline tumor biopsy.
  • Active or prior documented autoimmune or immunocompromisingconditions.
  • Uncontrolled hypertension
  • In the investigator's judgment, the subject has a medical history or current evidence of any disease, treatment, or laboratory abnormality that could confuse the results of the trial, interfere with the subject's participation throughout the trial, or is not in the subject's best interest to participate in the trial.

Study details
    Neoplasms
    Kidney Neoplasms
    Urologic Neoplasms
    Urogenital Neoplasms
    Female Urogenital Diseases
    Urogenital Diseases
    Kidney Diseases
    Urologic Diseases
    Male Urogenital Diseases
    Carcinoma
    Carcinoma
    Renal Cell
    Antineoplastic Agents
    Immune Checkpoint Inhibitors

NCT06114940

Jinling Hospital, China

3 May 2024

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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