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Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

Primary Purpose

MGMT-Unmethylated Glioblastoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib

About this trial

This is an interventional treatment trial for MGMT-Unmethylated Glioblastoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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:

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)

Sites / Locations

The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

1-year OS

1-year overall survival

Secondary Outcome Measures

PFS

Progression-Free Survival

Overall Survival

adverse event

Adverse events are described in terms of CTC AE 5.0

Health-related quality of life

Health-related quality of life are measured by the EORTC-QL30/BN20

Neurocognitive function

Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE)

Full Information

NCT ID

NCT04725214

First Posted

January 17, 2021

Last Updated

January 24, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04725214

Brief Title

Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2021 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MGMT-Unmethylated Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib

Other Intervention Name(s)

temozolomide capsule

Intervention Description

Anlotinib With STUPP Regimen

Primary Outcome Measure Information:

Title

1-year OS

Description

1-year overall survival

Time Frame

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

Secondary Outcome Measure Information:

Title

PFS

Description

Progression-Free Survival

Time Frame

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

Title

Description

Overall Survival

Time Frame

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

Title

adverse event

Description

Adverse events are described in terms of CTC AE 5.0

Time Frame

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

Title

Health-related quality of life

Description

Health-related quality of life are measured by the EORTC-QL30/BN20

Time Frame

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

Title

Neurocognitive function

Description

Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qichun Wei, MD

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Study Chair

Facility Information:

Facility Name

The Second Affiliated Hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

qichun wei, MD

Phone

086-0571-87783521

qichun_wei@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

yongjie shui, MM

Phone

086-0571-87783521

syjhz@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

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