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

Jinling Hospital, China

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Renal Cell; Immune Checkpoint Inhibitors; Male Urogenital Diseases; Antineoplastic Agents; Carcinoma; Urologic Diseases; Female Urogenital Diseases; Kidney Diseases; Neoplasms; Urogenital Neoplasms; Urogenital Diseases; Kidney Neoplasms; Urologic Neoplasms

Treatments: Drug: Toripalimab; Drug: Lenvatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06114940

2022NZKY-002-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Experimental group

Experimental group

Description:

Subjects received Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) followed by enucleation of renal tumor or partial nephrectomy or radical nephrectomy.

Treatment:

Drug: Lenvatinib

Drug: Toripalimab