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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
10-24Gy/5-8Gy/2-3f
400mg,q3w, until PD
200μg, D1-D7, q3w,≥8 cycles
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Overall response rate,ORR
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) u v1.1.
Time frame: Up to 2 years
progression free survival,PFS
Time from cycle 1, day 1 of treatment to disease progression or death due to any cause
Time frame: Up to 2 years
Disease control rate,DCR
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) o disease (SD) using RECIST v1.1.
Time frame: Up to 2 years
Overall survival,OS
Time from cycle 1, day 1 of treatment until death due to any cause
Time frame: Up to 2 years
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500mg/m2 ,d1 ,q3w,≥8 cycles