STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation

Inclusion Criteria:

* Newly diagnosed GBM confirmed by post-op pathology/biopsy, MGMT promoter methylation positive, no prior RT or chemo.
* Surgery/biopsy ≤ 21 days before enrollment.
* Age 18-75 years any gender.
* KPS ≥ 70.
* Organ function (no blood components or growth factors within 14 days):

  1. ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L.
  2. Total bilirubin ≤ 1.5 × ULN.
  3. ALT, AST ≤ 3 × ULN.
  4. Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min.
* Life expectancy ≥ 12 weeks.
* Stable or tapering corticosteroid dose for 14 days.
* Voluntary participation, signed informed consent, and good compliance.

Exclusion Criteria:

* Allergy to Lenvatinib, TMZ, or components.
* Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.
* Concurrent participation in another clinical trial (except observational).
* Comorbidities interfering with treatment:

  1. Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).
  2. Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).
* Evidence of increased intracranial pressure (midline shift \> 5 mm, papilledema, vomiting, decreased consciousness).
* History of drug/alcohol abuse.
* Pregnancy or lactation.
* Other conditions judged by the investigator (e.g., unstable heart/kidney disease, uncontrolled diabetes, mood disorders).