NCT07327411

Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors

A Single-arm, Multi-center, Prospective Clinical Study of Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multi-center, prospective clinical study aimed at exploring the efficacy and safety of cetuximab β combined with PRaG regimen in rescuing patients with EGFR-positive advanced refractory solid tumors.

Detailed description

This study is a single-arm, multicenter, prospective clinical trial aimed at exploring whether adding cetuximab β to PRaG regimen is effective in patients with EGFR-positive, advanced, refractory solid tumors. The goal is to achieve efficient and durable tumor immune responses by precisely identifying tumor cells and overcoming tumor heterogeneity. By exploring new treatment models, the study seeks to open new avenues for the treatment of patients with advanced refractory solid tumors and improve patient outcomes. Patients who meet the inclusion and exclusion criteria will be treated according to the following protocol. Treatment will continue until disease progression or the occurrence of intolerable toxicity. Imaging assessments will be conducted every 6 weeks.

Conditions

• Advanced Refractory Solid Tumors

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	10-24Gy/5-8Gy/2-3f
DRUG	PD-L1 inhibitor	400mg，q3w, until PD
DRUG	GM-CSF	200μg, D1-D7, q3w，≥8 cycles
DRUG	anti-EGFR monoclonal antibody	500mg/m2 ，d1 ，q3w，≥8 cycles

Timeline

• Start date: 2025-12-27
• Primary completion: 2027-02-10
• Completion: 2027-11-10
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: China