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

NCT07327411 | Not Yet Recruiting Phase 2

• 1 other identifier: JD-LK2025119-I01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression free survival，PFS

  Up to 2 years

• Disease control rate，DCR

  Up to 2 years

• Overall survival，OS

  Up to 2 years

Study Arms (1)

RT+PD-L1+GM-CSF+EGFR

EXPERIMENTAL

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; Drug: PD-L1 inhibitor; Drug: GM-CSF; Drug: anti-EGFR monoclonal antibody

Interventions

Hypofractionated radiotherapy RADIATION

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

RT+PD-L1+GM-CSF+EGFR

PD-L1 inhibitor DRUG

400mg，q3w, until PD

Also known as: Envafolimab Injection

RT+PD-L1+GM-CSF+EGFR

GM-CSF DRUG

200μg, D1-D7, q3w，≥8 cycles

RT+PD-L1+GM-CSF+EGFR

anti-EGFR monoclonal antibody DRUG

500mg/m2 ，d1 ，q3w，≥8 cycles

Also known as: cetuximab β

RT+PD-L1+GM-CSF+EGFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215163, China

Location

MeSH Terms

Interventions

Radiation Dose Hypofractionation; Immune Checkpoint Inhibitors; envafolimab; Granulocyte-Macrophage Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• liyuan zhang, PhD

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

liyuan zhang, PhD

CONTACT

67784827; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: December 27, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)