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.
Voluntarily sign a written informed consent form;
Age ≥18 years, male or female;
Eligible patients must have recurrent or metastatic advanced solid malignancies, with a confirmed pathological diagnosis or medical history, and pathology showing EGFR positivity (IHC 1, 2, or 3; for colorectal cancer, RAS/BRAF wild-type patients can be enrolled if EGFR is negative), with no clear guideline-recommended standard treatment or intolerance to standard therapy, and with measurable metastatic lesions (>1 cm);
Patient performance status is scored 0-3 according to the Eastern Cooperative Oncology Group (ECOG) criteria;
Pregnant or breastfeeding women；
Individuals with a history of other malignant diseases within the past 5 years, except for cured skin cancer and carcinoma in situ of the cervix；
Individuals with uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, where the investigator judges that the clinical severity may hinder the signing of informed consent or affect patient compliance with medication；
Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months；
Single group
Hypofractionated radiotherapy
Radiation10-24Gy/5-8Gy/2-3f
PD-L1 inhibitor
Drug400mg，q3w, until PD
GM-CSF
Drug200μg, D1-D7, q3w，≥8 cycles
anti-EGFR monoclonal antibody
Drug500mg/m2 ，d1 ，q3w，≥8 cycles
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.
progression free survival，PFS
Time from cycle 1, day 1 of treatment to disease progression or death due to any cause
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.
Overall survival，OS
Time from cycle 1, day 1 of treatment until death due to any cause
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This trial is not recruiting at the moment. You can still explore other options:
