Advanced Refractory Solid TumorsPhase 2NCT07327411
Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors
A Phase 2 study testing Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF in people with Advanced Refractory Solid Tumors, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Refractory Solid Tumors
- What is being tested?
- Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2025to 10 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215163
liyuan zhang, PhD, 67784827 ext. 0512, zhangliyuan126@126.com
About this study
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
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.
Read the 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
- Being tested
- Hypofractionated radiotherapy, PD-L1 inhibitor, GM-CSF, anti-EGFR monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
10-24Gy/5-8Gy/2-3f
PD-L1 inhibitorDrug
Also called Envafolimab Injection
400mg，q3w, until PD
GM-CSFDrug
200μg, D1-D7, q3w，≥8 cycles
anti-EGFR monoclonal antibodyDrug
Also called cetuximab β
500mg/m2 ，d1 ，q3w，≥8 cycles
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Hypofractionated radiotherapy; Drug: PD-L1 inhibitor; Drug: GM-CSF; Drug: anti-EGFR monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (3)
progression free survival，PFS
Time from cycle 1, day 1 of treatment to disease progression or death due to any cause
Measured: 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.
Measured: Up to 2 years
Overall survival，OS
Time from cycle 1, day 1 of treatment until death due to any cause
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start27 Dec 2025 (estimated)
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- liyuan zhang, PhD, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327411
- Sponsor's protocol ID
- JD-LK2025119-I01
- Status last verified
- Nov 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07327411
- Acronym / sponsor ID
- JD-LK2025119-I01
- Conditions
- Advanced Refractory Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 27 Dec 2025 (estimated)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT+PD-L1+GM-CSF+EGFR | Experimental | Radiation: Hypofractionated radiotherapy, Drug: PD-L1 inhibitor, Drug: GM-CSF, Drug: anti-EGFR monoclonal antibodyRadiation: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapy10-24Gy/5-8Gy/2-3f | Radiation | RT+PD-L1+GM-CSF+EGFR |
| PD-L1 inhibitorAlso: Envafolimab Injection400mg，q3w, until PD | Drug | RT+PD-L1+GM-CSF+EGFR |
| GM-CSF200μg, D1-D7, q3w，≥8 cycles | Drug | RT+PD-L1+GM-CSF+EGFR |
| anti-EGFR monoclonal antibodyAlso: cetuximab β500mg/m2 ，d1 ，q3w，≥8 cycles | Drug | RT+PD-L1+GM-CSF+EGFR |
Primary outcome
Overall response rate，ORR
Time frame: Up to 2 years
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) u v1.1.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
liyuan zhang, PhD principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF in people with Advanced Refractory Solid Tumors, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact liyuan zhang, PhD (67784827 ext. 0512, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate，ORR (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.