Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

NCT ID: NCT04725214

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.

Detailed Description

For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).

Conditions

MGMT-Unmethylated Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14)

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

Anlotinib With STUPP Regimen

Interventions

Anlotinib

Anlotinib With STUPP Regimen

Intervention Type: DRUG

Other Intervention Names

temozolomide capsule

Eligibility Criteria

Inclusion Criteria

1. Aged 18-70 years,

2. Histologically proven diagnosis of glioblastoma (WHO grade IV),

3. Have received standard STUPP treatment plan,

4. Gross resection or partial resection of the tumor (confirmed by MRI)> 50%,

5. The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,

6. No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L

8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 10.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 11.Able to provide written informed consent

Exclusion Criteria

1. Recurrent or multiple malignant gliomas

2. Subtentorial glioblastoma or metastatic lesions outside the skull

3. Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery

4. Previously received radiation therapy for the head and neck cancer

5. Have received any antibody treatment before

6. 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

7. Evidence of bleeding diathesis or coagulopathy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qichun Wei, MD

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

qichun wei, MD

Role: primary

qichun_wei@zju.edu.cn

086-0571-87783521

yongjie shui, MM

Role: backup

syjhz@163.com

086-0571-87783521

Other Identifiers

2020-780

Identifier Type: -

Identifier Source: org_study_id