NCT07754734Not yet recruitingPhase 2
STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation
STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 10 Aug 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Dongguan People's Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT07754734
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 10 Aug 2026 to the primary completion date, 31 Jul 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.
- Concurrent participation in another clinical trial (except observational).
Other illness
- Allergy to Lenvatinib, TMZ, or components.
- Comorbidities interfering with treatment:
- Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).
- Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).
- History of drug/alcohol abuse.
- Other conditions judged by the investigator (e.g., unstable heart/kidney disease, uncontrolled diabetes, mood disorders).
Other
- Evidence of increased intracranial pressure (midline shift \> 5 mm, papilledema, vomiting, decreased consciousness).
- Pregnancy or lactation.
Who the study is looking for
- 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):
- ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L.
- Total bilirubin ≤ 1.5 × ULN.
- ALT, AST ≤ 3 × ULN.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.