🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07327411
Starting soon Phase 2

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

NCT07327411 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Soochow University
Phase
Phase 2
Started
2025-12-27
Last updated
2026-01-08

Condition(s) studied

Advanced Refractory Solid Tumors

Investigational drug(s) / intervention(s)

Hypofractionated radiotherapyPD-L1 inhibitor →GM-CSF →anti-EGFR monoclonal antibody

Hypofractionated radiotherapy: 10-24Gy/5-8Gy/2-3f

PD-L1 inhibitor: 400mg,q3w, until PD

GM-CSF: 200μg, D1-D7, q3w,≥8 cycles

anti-EGFR monoclonal antibody: 500mg/m2 ,d1 ,q3w,≥8 cycles

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu

More Second Affiliated Hospital of Soochow University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327411 on ClinicalTrials.gov ↗ ← All trials in China