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Glioma, MalignantPhase 2NimotuzumabNCT07707973

Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

A Phase 2 study testing nimotuzumab, Temozolomide and Radiotherapy in people with Glioma, Malignant, run by Tianjin First Central Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This is a prospective, single-arm study. The study population consists of adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma who have radiographic residual tumor following surgical resection. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioma, Malignant
What is being tested?
nimotuzumab, Temozolomide and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
3 Jul 2026to 3 Jun 2029
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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).

About this study

Official title: A Single-arm, Phase II Study of Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

This is a prospective, single-arm study. The study population consists of adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma who have radiographic residual tumor following surgical resection. Participants will receive nimotuzumab in combination with the standard Stupp regimen after glioma surgery.

Read the detailed description

This is a prospective, single-arm study designed to enroll 50 adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma and radiographic residual tumor following surgical resection (primary inclusion criteria). Patients are excluded if they are EGFR-negative; have previously received chemotherapy, anti-EGFR therapy, or radiotherapy; have a history of other malignancies within the past 5 years; present with severe comorbidities or active infections; or experience persistent vomiting that may interfere with the oral administration of temozolomide (TMZ). Following surgery, participants will receive nimotuzumab in combination with the standard Stupp regimen.

Being tested
nimotuzumab, Temozolomide, Radiotherapy
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nimotuzumabDrug

    Nimotuzumab 200 mg will be administered via intravenous infusion once weekly for 6 weeks, followed by 200 mg via intravenous infusion once every 4 weeks for a total of 6 doses.

  • TemozolomideDrug

    Temozolomide will be administered orally at a dose of 150-200 mg/m²/day for 5 consecutive days. Each cycle lasts 28 days, for a total of 6 cycles.

  • RadiotherapyRadiation

    PTV：60Gy/2Gy/30f，6weeks

Study groups in NCT07707973
Study groupRoleWhat they receive
nimotuzumab groupExperimentaltreatment group
Receives: Drug: nimotuzumab; Drug: Temozolomide; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    defined as the time from randomization (or the initiation of treatment) to the first documented tumor progression or death from any cause, whichever occurs first

    Measured: from the initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 100 weeks

Secondary outcomes (4)

  1. Overall Survival

    defined as the time from randomization (or the initiation of treatment) to death from any cause.

    Measured: from the initiation of treatment，up to 100 weeks

  2. Objective Response Rate

    defined as the proportion of patients who achieve a Complete Response (CR) or a Partial Response (PR) out of the total number of evaluable patients

    Measured: through study completion, an average of 1 year

  3. Disease Control Rate

    defined as the proportion of patients who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of the total number of evaluable patients

    Measured: through study completion, an average of 1 year

  4. Adverse Event

    any unfavorable or unintended medical occurrence in a patient or clinical trial subject administered a pharmaceutical product or device, which does not necessarily have a causal relationship with the treatment

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start3 Jul 2026 (estimated)
  3. Primary completion3 Jan 2028 (estimated)
  4. Study completion3 Jun 2029 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07707973
Sponsor's protocol ID
IST-Nim-GBM-04
Acronym
Nimotuzumab
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nimotuzumab, Temozolomide and Radiotherapy in people with Glioma, Malignant, run by Tianjin First Central Hospital.

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 9 inclusion and 3 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: from the initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 100 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07707973.

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 16 Jul 2026.

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