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

NCT ID: NCT07327411

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-27
• Study Completion Date: 2027-11-10

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT+PD-L1+GM-CSF+EGFR

Radiation: Hypofractionated radiotherapy 10-24Gy/5-8Gy/2-3f Drug1: PD-L1 inhibitor，Envafolimab 400mg，d1，q3w, until PD Drug2: GM-CSF 200μg, D1-D7,q3w, ≥8 cycles Drug3: anti-EGFR monoclonal antibody，cetuximab β 500mg/m2， d1， q3w, ≥8 cycles

Group Type: EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type: RADIATION

10-24Gy/5-8Gy/2-3f

PD-L1 inhibitor

Intervention Type: DRUG

400mg，q3w, until PD

GM-CSF

Intervention Type: DRUG

200μg, D1-D7, q3w，≥8 cycles

anti-EGFR monoclonal antibody

Intervention Type: DRUG

500mg/m2 ，d1 ，q3w，≥8 cycles

Interventions

Hypofractionated radiotherapy

10-24Gy/5-8Gy/2-3f

Intervention Type: RADIATION

PD-L1 inhibitor

400mg，q3w, until PD

Intervention Type: DRUG

GM-CSF

200μg, D1-D7, q3w，≥8 cycles

Intervention Type: DRUG

anti-EGFR monoclonal antibody

500mg/m2 ，d1 ，q3w，≥8 cycles

Intervention Type: DRUG

Other Intervention Names

Envafolimab Injection; cetuximab β

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

liyuan zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Soochow University

Locations

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Central Contacts

liyuan zhang, PhD

Role: CONTACT

zhangliyuan126@126.com

67784827 ext. 0512

Facility Contacts

liyuan zhang, PhD

Role: primary

zhangliyuan126@126.com

67784827 ext. 0512

Other Identifiers

JD-LK2025119-I01

Identifier Type: -

Identifier Source: org_study_id