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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Refractory Solid Tumors
• Intervention / Treatment: Radiation: Hypofractionated radiotherapy; Drug: PD-L1 inhibitor; Drug: GM-CSF; Drug: anti-EGFR monoclonal antibody

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: liyuan zhang, PhD; Phone Number: 0512 67784827; Email: zhangliyuan126@126.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215163
      • The Second Affiliated Hospital of Soochow University
      • Contact: liyuan zhang, PhD; Phone Number: 0512 67784827; Email: zhangliyuan126@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: Hypofractionated radiotherapy; 10-24Gy/5-8Gy/2-3f; Drug: PD-L1 inhibitor; 400mg，q3w, until PD; Other Names: Envafolimab Injection; Drug: GM-CSF; 200μg, D1-D7, q3w，≥8 cycles; Drug: anti-EGFR monoclonal antibody; 500mg/m2 ，d1 ，q3w，≥8 cycles; Other Names: cetuximab β

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival，PFS	Time from cycle 1, day 1 of treatment to disease progression or death due to any cause	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.	Up to 2 years
Overall survival，OS	Time from cycle 1, day 1 of treatment until death due to any cause	Up to 2 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: liyuan zhang, PhD, Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): December 27, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): November 10, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biological Factors; Carbohydrates; Intercellular Signaling Peptides and Proteins; Glycoproteins; Glycoconjugates; Radiotherapy; Colony-Stimulating Factors; Hematopoietic Cell Growth Factors; Cytokines; Dose Fractionation, Radiation; Radiotherapy Dosage; Immune Checkpoint Inhibitors; Radiation Dose Hypofractionation; envafolimab; Granulocyte-Macrophage Colony-Stimulating Factor
• Other Study ID Numbers: JD-LK2025119-I01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No