Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated radiotherapy, PD-L1 inhibitor, GM-CSF, anti-EGFR monoclonal antibody.
- Who it may be relevant to
- Registry conditions: Advanced Refractory Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Overall response rate，ORR [Time frame: Up to 2 years]
Secondary outcome measures (3)
- progression free survival，PFS [Time frame: Up to 2 years]
- Disease control rate，DCR [Time frame: Up to 2 years]
- Overall survival，OS [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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;
- Estimated life expectancy ≥3 months;
- No history of severe hematopoietic, cardiac, pulmonary, hepatic, or renal dysfunction or immunodeficiency;
- Good compliance.
Exclusion 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；
- Individuals requiring immunosuppressive therapy due to organ transplantation；
- Known significant active infection, or if the investigator judges there is a significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other severe uncontrolled comorbid conditions；
- Individuals allergic to any component of the study drug；
- Individuals with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immune-related diseases requiring long-term oral corticosteroid treatment；
- Individuals currently with acute or chronic tuberculosis infection (positive T-spot test, chest X-ray showing suspicious tuberculosis lesions)；
- Other situations deemed unsuitable for enrollment by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07327411 · JD-LK2025119-I01