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Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

ConditionGlioma, Malignant
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin First Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • nimotuzumab

    Drug

    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.

  • Temozolomide

    Drug

    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.

  • Radiotherapy

    Radiation

    PTV：60Gy/2Gy/30f，6weeks

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: nimotuzumab groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

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

Secondary outcomes

1

Overall Survival

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

Time frame
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

Time frame
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

Time frame
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

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin First Central Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: