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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119674
• Other study ID #: GBM-AS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 19, 2019
• Est. completion date: August 23, 2022

Study information

• Verified date: September 2023
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Drug is Anlotinib.
Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .
• Drug is Temozolomide Capsule.
Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .

Radiation:
• Radiotherapy was initiated 4 to 6 weeks postoperatively.
Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.

Locations

Country	Name	City	State
China	Zhejiang cancer hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-Free Survival	from enrollment to progression or death (for any reason),assessed up to 18months
Secondary	OS	Overall Survival	from enrollment to death (for any reason).assessed up to 24 months
Secondary	adverse event	Adverse events are described in terms of CTC AE 5.0	from enrollment to death (for any reason).assessed up to 24 months
Secondary	Health-related quality of life	Health-related quality of life are measured by the EORTC-QL30/BN20.	from enrollment to death (for any reason).assessed up to 24 months
Secondary	Neurocognitive function	Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).	from enrollment to death (for any reason).assessed up to 24 months