Clinical trial NCT04119674: Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
Official title: Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
2. 2 \~ 6 weeks after operation; the surgical incision healed well;
3. Presence of lesions evaluable according to Rano criteria;
4. Aged 18-70 years;
5. Karnofsky performance status (KPS) ≥ 60;
6. The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
7. No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
8. Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
9. Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
10. Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
11. Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
12. 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;
13. Patient is sufficiently compliant with study and follow-up procedures;
14. 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 Criteria:

1. Secondary glioblastoma;
2. Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
3. 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);
4. Pregnant or lactating women;
5. Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
6. Evidence of hereditary bleeding constitution or coagulation disorders;
7. Patients requiring anticoagulant therapy due to other diseases;

Primary outcomes:
measure: PFS
timeFrame: from enrollment to progression or death (for any reason),assessed up to 18months
Secondary outcomes:
measure: OS
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: adverse event
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: Health-related quality of life
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: Neurocognitive function
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Chen Ming
role: PRINCIPAL_INVESTIGATOR
References: