Clinical trial · Interventional
TMZ Plus Apatinib in Newly Diagnosed High-grade Glioma:RCT
A Randomized Controlled Clinical Trial of Temozolomide Plus Apatinib in Newly Diagnosed High-grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Glioma is the most common primary malignant Brain Tumor. Although the traditional treatment (surgery, radiotherapy and chemotherapy) has been actively carried out, the curative effect of High grade glioma (HGG) is still poor.On the basis of a lot of exploration, the union medication has become a hot spot. Malignant glioma has obvious neovascularization and inhibiting angiogenesis can inhibit tumor proliferation and invasion.Studies have found that inhibiting VEGFR-2 can can reduce neovascularization and inhibit tumor growth. NCCN clinical practice guidelines recommend bevacizumab(BEV) for the treatment of recurrent malignant gliomas. AVAglio&RTOG 0825 subgroup analysis showed that TMZ combined with antiangiogenic drugs may have advantages in the first-line treatment of patients with IDH1 wild-type high grade glioma.However, some studies have shown that bevacizumab can lead to rapid deterioration due to hypoxia or phenotypic changes. So it is urgent to find new antiangiogenic drugs. Apatinib is an oral small molecule antiangiogenic targeted drug. Apatinib plus temozolomide has been shown to be effective and tolerable in recurrent glioma. So the investigators aimed to evaluate the efficacy and safety of temozolomide combined with apatinib in the new diagnosis of high-grade glioma,and to explore the new first-line treatment of HGG, especially to TMZ insensitivity patients(MGMT gene promoter unmethylated) and poor prognosis (IDH1 wild type) population. And Find out the benefit groups of the two drugs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temozolomide and apatinib
- description
- Patients have treated with postoperative concurrent chemoradiation. Then Temozolomide (150mg/m2/d d1-5 in the first cycle, followed by 200mg/m2/d d1-5 q28d) + apatinib (500mg/d QD). After 6 cycles,apatinib single drug maintained until progress.
- interventionNames
- Drug: apatinib
- Drug: Temozolomide
- type
- ACTIVE_COMPARATOR
- label
- Temozolomide
- description
- Patients were treated with postoperative concurrent chemoradiation.Then Temozolomide alone chemotherapy 6 cycles(first cycle 150mg/m2/d d1-5, later 200mg/m2/d d1-5 q28d).
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years; 2. Pathological or cytological diagnosis of glioma (WHO Ⅲ or Ⅳ); 3. KPS score ≥ 60; 4. The expected survival period is ≥ 3 months; 5. Blood routine examination is basically normal: a. HB ≥ 90 G /L; b. the ANC ≥ 1.5 x 10\^9/L; c. PLT≥ 80 x 10\^9/L (without blood transfusion within 2 weeks, or G-CSF and other hematopoietic stimulator correction) ; 6. Normal liver and kidney function. Exclusion Criteria: 1. Pregnant or lactating women; 2. Second primary malignancy; 3. Severe lung infection; 4. with high blood pressure although treated with medication; 5. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QT interval \> 440 ms) or grade II cardiac insufficiency; 6. Conditions that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 7. Abnormal coagulation function (INR\>1.5 or PT\>ULN+4s or APTT \>1.5 ULN); 8. Haemorrhagic tendencies or being treated with thrombolysis or anticoagulation; 9. ≥CTCAE level 2 Pulmonary hemorrhage or ≥CTCAE level 3 other organ hemorrhage occurred within 4 weeks before the first administration of the study drug; 10. Arteriovenous thrombosis in 6 months prior to first administration, Such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 11. Small doses of warfarin(1mg/day) or heparin(80-100mg/day) is permitted unless INR ≤1.5; 12. Serious heart, lung and bone marrow impairment; 13. History of severe hypertension or cerebral hemorrhage
References
Publications (0)
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