New cocktail therapy aims to shrink Hard-to-Treat tumors
NCT ID NCT07327411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial will test a combination of four treatments—cetuximab β (a targeted antibody), radiation, an immunotherapy drug (envafolimab), and a growth factor (GM-CSF)—in 40 adults with advanced solid tumors that have EGFR protein and are no longer responding to standard care. The goal is to see if this mix can shrink tumors or slow disease progression. The study is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cetuximab β (anti-EGFR antibody) combined with hypofractionated radiotherapy, envafolimab (PD-L1 inhibitor), and GM-CSF
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial (40 people) with no control group, so results may not apply broadly. The combination also carries risks of side effects from radiation and immunotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215163, China
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