Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

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

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

Study Overview

• Status: Recruiting
• Conditions: MGMT-Unmethylated Glioblastoma
• Intervention / Treatment: Drug: Anlotinib

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).

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14)	Drug: Anlotinib; Anlotinib With STUPP Regimen; Other Names: temozolomide capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year OS	1-year overall survival	from enrollment to death (for any reason).assessed up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free Survival	from enrollment to progression or death (for any reason),assessed up to 24months
OS	Overall Survival	from enrollment to death (for any reason).assessed up to 24 months
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Qichun Wei, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: 2020-780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No