NCT07256223

A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread

A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases

• Status: Not Yet Recruiting
• 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 an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.

Detailed description

The study procedure comprises three phases: a screening period, a treatment period, and a follow-up period. Patients with previously untreated advanced clear cell renal cell carcinoma and liver metastases will be screened. Those who meet the inclusion criteria and provide written informed consent will receive treatment. The treatment regimen consists of envafolimab combined with lenvatinib administered over 8 treatment cycles, with each cycle defined as 14 days. enrolled patients will undergo biopsy of liver metastases before the first dose and after 8 cycles of treatment (or upon confirmation of disease progression). Imaging examinations of the kidneys and liver will be conducted during the screening period, after 4 cycles of treatment, and after 8 cycles of treatment. Following the initiation of therapy, systemic imaging will be performed every 6 months. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Safety evaluations will be based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, with relevant laboratory tests performed during each treatment cycle. Adverse events will be recorded from the time of enrollment until 30 days after the last dose. For serious adverse events or those considered related to envafolimab, the recording period will be extended to 90 days after the end of treatment.

Conditions

• Clear Cell Renal Cell Cancer (ccRCC)
• Liver Metastasis

Interventions

Type	Name	Description
DRUG	Envafolimab+Lenvatinib	To evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-11-01
• Completion: 2028-05-30
• First posted: 2025-12-01
• Last updated: 2025-12-01