Status:
COMPLETED
Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
- 2 \~ 6 weeks after operation; the surgical incision healed well;
- Presence of lesions evaluable according to Rano criteria;
- Aged 18-70 years;
- Karnofsky performance status (KPS) ≥ 60;
- The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
- No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
- Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
- Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
- Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
- Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
- Patient is sufficiently compliant with study and follow-up procedures;
- Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.
Exclusion
- Secondary glioblastoma;
- Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
- Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- Pregnant or lactating women;
- Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
- Evidence of hereditary bleeding constitution or coagulation disorders;
- Patients requiring anticoagulant therapy due to other diseases;
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04119674
Start Date
March 19 2019
End Date
August 23 2022
Last Update
September 22 2023
Active Locations (1)
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1
Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022