Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

NCT04725214 | Unknown Phase 2

• 1 other identifier: 2020-780
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

MGMT-Unmethylated Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 1-year OS

  1-year overall survival

  from enrollment to death (for any reason).assessed up to 12 months

Secondary Outcomes (5)

• PFS

  from enrollment to progression or death (for any reason),assessed up to 24months

• OS

  from enrollment to death (for any reason).assessed up to 24 months

• adverse event

  from enrollment to death (for any reason).assessed up to 24 months

• Health-related quality of life

  from enrollment to death (for any reason).assessed up to 24 months

• Neurocognitive function

  from enrollment to death (for any reason).assessed up to 24 months

Study Arms (1)

Experimental

EXPERIMENTAL

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

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib With STUPP Regimen

Also known as: temozolomide capsule

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years,
• Histologically proven diagnosis of glioblastoma (WHO grade IV),
• Have received standard STUPP treatment plan,
• Gross resection or partial resection of the tumor (confirmed by MRI)\> 50%,
• The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
• 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
• 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

You may not qualify if:

• Recurrent or multiple malignant gliomas
• Subtentorial glioblastoma or metastatic lesions outside the skull
• Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
• Previously received radiation therapy for the head and neck cancer
• Have received any antibody treatment before
• 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
• Evidence of bleeding diathesis or coagulopathy
• Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

anlotinib; Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Qichun Wei, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 26, 2021
• Study Start: January 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)