Skip to content

A prospective, single-arm clinical study of antiangiogenic drugs combined with temozolomide in the treatment of postoperative recurrent Glioblastoma multiforme under the guidance of molecular pathology

A prospective, single-arm clinical study of antiangiogenic drugs combined with temozolomide in the treatment of postoperative recurrent GBM under the guidance of molecular pathology

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056169
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

Antiangiogenic drugs combined with temozolomide group:Anlotinib
Antiangiogenic drugs combined with temozolomide group:Temozolomide

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age is 18-75 years old; 2. ECOG performance status (PS) 0~2 points; 3. The expected survival time is not less than 12 weeks; 4. The supratentorial space occupying lesion was pathologically diagnosed as glioblastoma after the initial operation by biopsy or surgery; 5. Have the necessary molecular pathological test results; 6. Receive radiotherapy after operation, and the time interval from the last radiotherapy is = 3 months; 7. If the patient has received chemotherapy, the toxic reaction has recovered to = 1 level when the last chemotherapy is >= 4 weeks away; 8. MRI confirmed that the tumor had definite recurrence, the diameter of the enhancement focus was >= 1cm, >= 2 layers (layer spacing was 5mm), or it was confirmed as recurrence by pathology after biopsy or surgery again; 9. Time interval from the last biopsy or operation >= 4 weeks; If the patient is being treated with glucocorticoid, the dosage of glucocorticoid should be stable or reduced at least 5 days before baseline MRI; 10. The main organs function normally, and the laboratory test results have no obvious abnormalities; 11. The observed patients volunteered to join the study and signed the informed consent form, with good compliance and cooperation in follow-up; 12. Patients who believe that the treatment plan may benefit and have signed the informed consent form for trial treatment voluntarily accepting the plan.

Exclusion criteria

Exclusion criteria: 1. People allergic to anti angiogenic targeted drugs; 2. Those with serious heart disease or medical history (angina pectoris requiring medical treatment, stubborn hypertension, congestive heart failure, myocardial infarction, high-risk uncontrollable arrhythmia, heart valve disease); 3. Inflammation, unhealed wound, ulcer or bleeding disease; 4. Second primary malignant tumor; 5. Those who have uncontrollable neurological, mental diseases or mental disorders, poor compliance, and can not cooperate with and describe the treatment response; 6. Patients participating in other clinical trials at the same time; 7. Other conditions that the investigator thinks the patient is not suitable to participate in this test.

Design outcomes

Primary

MeasureTime frame
progression-free survival;overall survival time;

Countries

China

Contacts

Public ContactQingxin Li

The First Affiliated Hospital of Anhui Medical University

lxq202112@163.com+86 15855110186

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026