NCT06255223

A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy

An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Multimodal Radiotherapy in the Treatment of Renal Cell Carcinoma Progressed After Prior Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this single-center clinical study was to evaluate the disease control rate(DCR) and safety of multimodal radiotherapy in the treatment of patients with renal cell carcinoma (RCC) progressed after prior immunotherapy.

Detailed description

The patients who were clinically diagnosed advanced renal cell carcinoma with progression after 1-2 previous systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), with two or more metastases at different sites, will be evaluated by the researchers. For eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment. The disease control rate and safety of this treatment will be evaluated.

Conditions

• Renal Cell Carcinoma
• Radiotherapy
• Immune Checkpoint Inhibitor

Interventions

Type	Name	Description
RADIATION	High-dose Radiotherapy (HDRT)	SBRT was adopted, and radiotherapy plan was made according to the location and size of lesions (total dose 20-70Gy, 5-12Gy every time).
RADIATION	Low-dose Radiotherapy (LDRT)	Radiotherapy plan was made according to the location and size of lesions (total dose 2Gy, 1Gy every time). After completing SBRT, LDRT was performed on as many metastatic sites as possible.
DRUG	Anti-PD-1 monoclonal antibody	At the end of multimodal radiotherapy, immunotherapy was given within 7 days and in a subsequent LDRT. The maximum duration is 24 months.

Timeline

• Start date: 2023-12-15
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-02-13
• Last updated: 2025-09-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study