NCT05124431

Anlotinib Plus Everolimus as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

Single Arm, Single Center, Prospective, Phase II Clinical Study of Anlotinib Hydrochloride Capsule Combined With Everolimus in the First-line Treatment of Advanced Non Clear Cell Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, single-arm, phase 2 study to evaluate the efficacy and safety of anlotinib hydrochloride plus everolimus in patients with advanced non clear renal cell carcinoma as first-line treatment.

Detailed description

This is a single-arm, phase II trial in non-clear renal cell carcinoma patients. The purpose of this trial is to evaluate the safety and efficacy of anlotinib hydrochloride combined with everolimus in patients with no systematic treatment advanced non clear renal cell carcinoma. The primary objective: Overall Response Rate(ORR)(according to RECIST version 1.1). The second objectives: progression free survival (PFS), disease control rate (DCR), Overall Survival(OS) and safety.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor.
DRUG	everolimus	5mg po，qd

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: China