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

Phase 1

Completed

• Conditions: Glioblastoma
• Interventions: Drug: Drug is Anlotinib.; Drug: Drug is Temozolomide Capsule.; Radiation: Radiotherapy was initiated 4 to 6 weeks postoperatively.

• Registration Number: NCT04119674
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-06
• Study First Posted: 2019-10-08
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	Drug is Anlotinib.	single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy: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.
single-arm	Radiotherapy was initiated 4 to 6 weeks postoperatively.	single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy: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.
single-arm	Drug is Temozolomide Capsule.	single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy: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.

Primary Outcome Measures

Name	Time	Method
PFS	from enrollment to progression or death (for any reason),assessed up to 18months	Progression-Free Survival

Secondary Outcome Measures

Name	Time	Method
OS	from enrollment to death (for any reason).assessed up to 24 months	Overall Survival
adverse event	from enrollment to death (for any reason).assessed up to 24 months	Adverse events are described in terms of CTC AE 5.0
Health-related quality of life	from enrollment to death (for any reason).assessed up to 24 months	Health-related quality of life are measured by the EORTC-QL30/BN20.
Neurocognitive function	from enrollment to death (for any reason).assessed up to 24 months	Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).

Trial Locations

Locations (1)

Zhejiang cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China