Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

MGMT-Unmethylated Glioblastoma Clinical Trial

Official title:

Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725214
• Other study ID #: 2020-780
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma
• MGMT-Unmethylated Glioblastoma

Intervention

Drug:
• Anlotinib
Anlotinib With STUPP Regimen

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year OS	1-year overall survival	from enrollment to death (for any reason).assessed up to 12 months
Secondary	PFS	Progression-Free Survival	from enrollment to progression or death (for any reason),assessed up to 24months
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