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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Lenvatinib

Criteria

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.