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Targeted antibody may boost brain cancer treatment after incomplete surgery

NCT ID NCT07707973

Disease control Sponsor: Tianjin First Central Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding nimotuzumab—an antibody that blocks a protein called EGFR—to the standard Stupp regimen (temozolomide plus radiotherapy) can improve outcomes for adults with glioblastoma that was not fully removed by surgery. Participants must have EGFR-positive tumors and measurable residual disease. The study measures progression-free survival, overall survival, and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nimotuzumab, an experimental antibody that targets EGFR, combined with standard temozolomide chemotherapy and radiotherapy
What this could lead to
If successful, this combination could offer a new standard treatment option for people with EGFR-positive glioblastoma that was not fully removed by surgery.
What could go wrong
This is a small, single-arm phase 2 study, so results may not be definitive. The drug may cause side effects like infusion reactions or fatigue, and it may not improve survival compared to current treatments.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1）Aged 18 to 75 years. * 2）Newly diagnosed glioblastoma consistent with the World Health Organization (WHO) Classification of Tumours of the Central Nervous System, 5th edition. * 3）Epidermal growth factor receptor (EGFR)-positive status confirmed by immunohistochemistry (defined as brown-yellow staining in \>10% of tumor cells). * 4）Partial surgical resection with radiographically measurable residual tumor. * 5）Karnofsky Performance Status (KPS) score ≥ 50% (with KPS decline attributable to the tumor). * 6）Adequate renal function, defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance \> 60 mL/min. * 7）Adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and serum transaminases ≤ 3 times the ULN. * 8）Adequate hematologic function, defined as a white blood cell count ≥ 3,000/μL or an absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 10 g/dL. * 9）An interval of 2 to 6 weeks between surgical resection and the initiation of radiotherapy (RT). Exclusion Criteria: * 1）EGFR-negative status. * 2）Prior treatment with chemotherapy, anti-EGFR therapy, or radiotherapy; or a history of other malignancies within the past 5 years. * 3）Presence of severe comorbidities or active infections, or persistent vomiting that may interfere with the oral administration of temozolomide (TMZ).

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma malignant glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioma, malignant

How to take part

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  1. The official record

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