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Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Immune Checkpoint Inhibitors Clinical Trial

Official title:
Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Clinical Trial Summary

Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma. Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells <10% in the primary tumor after nephrectomy. Study Design: Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs. Sample Size: 20 participants. Patient Grouping: Non-randomized. Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06279403
Study type Interventional
Source RenJi Hospital
Contact
Status Not yet recruiting
Phase Phase 2
Start date March 1, 2024
Completion date March 1, 2029
View Details
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