NCT06455072

Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

Nituzumab Plus Serplulimab Combined With SBRT in Recurrent Advanced Cervical Cancer: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In recurrent advanced cervical cancer, patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy. However, immune checkpoint inhibitor's combination therapy has become a promising strategy for advanced cervical cancer. Epidermal Growth Factor Receptor (EGFR) is overexpressed in cervical cancer cells. Stereotactic radiotherapy (SBRT) can enhance the efficacy of immunotherapy.

Detailed description

In recurrent advanced cervical cancer, patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy. However, immune checkpoint inhibitor's combination therapy has become a promising strategy for advanced cervical cancer. Epidermal Growth Factor Receptor (EGFR) is overexpressed in cervical cancer cells. Stereotactic radiotherapy (SBRT) can enhance the efficacy of immunotherapy. Nituzumab is a humanized monoclonal antibody that binds to the epidermal growth factor receptor. Serplulimab is a fully humanized, high-affinity monoclonal antibody against programmed cell death-1 (PD-1). This phase II, single-arm study aims to evaluate the efficacy and safety of Nituzumab plus Serplulimab combined with SBRT in patients with recurrent advanced cervical cancer. Patients who have failed in standard chemotherapy，histopathologically confirmed recurrent advanced squamous cell cervical carcinoma regardless of programmed cell death-Ligand 1 (PD-L1) expression. Patients who have achieved the response state or come to stably at least six months after immunotherapy were allowed. There was at least one lesion for SBRT in addition to target lesions. ECOG 0-1 were considered eligible for enrollment. Nituzumab was given intravenously (400mg qw, 21 days per cycle), and Serplulimab was administered intravenously (200mg once every 3 weeks).The dose was 30-50 Gy in three to five fractions and the number of lesions was no more than four by SBRT. The treatment was continued until disease progression, death or intolerant toxicity. The primary endpoint was objective response rate (ORR) and the secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Nituzumab	EGFR monoclonal antibody
DRUG	Serplulimab	PD-1 (programmed death receptor 1) monoclonal antibody

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: China