NCT06211790

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma: a Single-center, Prospective, Phase II Umbrella Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Based on different subtypes, subjects will be placed in one of three treatment groups to explore individual efficacy and safety of various treatment regimen.

Detailed description

MSKCC Prognostic Model and IMDC(International Metastatic Renal Cell Carcinoma Database Consortium) Criteria are derived from cytokine and targeted therapy era, separately. In order to adapt to immunotherapy era and achieve the precision treatment in patients with kidney cancer, a new molecular typing map is urgent to be set up. In this study, patients with renal cell carcinoma will be divided into three types, FuDan-GP1(glycoprotein I) subtype (targeted sensitive type), FuDan-GP2(glycoprotein 2) subtype (Cold tumor) and FuDan-GP3(glycoprotein 3) subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs(tyrosine kinase inhibitor) and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications. Based on the gene proteomic analysis of tissue samples, a molecular typing map was set up and the efficacy and safety of anlotinib, anlotinib combined with everolimus, and anlotinib combined with tislelizumab in the first-line treatment of unresectable or metastatic renal clear cell carcinoma will be evaluated.

Conditions

• Kidney Cancer
• Renal Cell Carcinoma
• Renal Clear Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib, Everolimus and Tislelizumab	Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: China