Overview

Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

Status:
Unknown status

Trial end date:
2021-05-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zhejiang Cancer Hospital

Treatments:

Temozolomide

Criteria

Inclusion Criteria:

1.Histologically proven diagnosis of glioblastoma (WHO grade IV) 2.1.4-6 weeks after
surgery and incision has healed 3.Patients with quantifiable target lesions according to
RANO criteria 4.Aged 18-70 years 5.Karnofsky performance status ≥ 60 6.Corticosteroids
doses has been stabilized or decreased within 5 days 7.No previous radiotherapy,
chemotherapy, immunotherapy or biotherapy 8.Adequate bone marrow function: Hemoglobin ≥
100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L 9.Adequate renal
function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60
ml/min 10.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x
UNL，ALP≤5x UNL 11.Adequate coagulation function: PT ≤ 5 seconds above the UNL， APTT≤ 5
seconds above the UNL 12.For females of child-bearing potential, negative serum pregnancy
test within 14 days prior to registration. Women of childbearing potential and male
participants must practice adequate contraception during participation in the study and
within 8 weeks after the last administration of the drug 13.Subject is willing and able to
comply with the protocol for the duration of the study including undergoing treatment and
scheduled visits and examinations including follow up 14.Able to provide written informed
consent

Exclusion Criteria:

1. Recurrent malignant gliomas

2. Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in
situ of cervix)

3. Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial
or fungal infection，Unstable angina and/or congestive heart failure within the last 6
months，co-morbidity with immunosuppressive therapy

4. Pregnant or lactating women

5. women of childbearing potential and men who are sexually active and not willing/able
to use medically acceptable forms of contraception

6. Evidence of bleeding diathesis or coagulopathy

7. Patients on anticoagulants for co-morbidity