Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

Summary

For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.

Conditions

• Glioblastoma

Interventions

DRUG

Anlotinib Hydrochloride

Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

RADIATION

Radiation therapy

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

DRUG

Temozolomide

Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• Nanxishan Hospital

  collaborator UNKNOWN

• LiuZhou People's Hospital

  collaborator OTHER

• Affiliated Hospital of Guilin University

  collaborator UNKNOWN

• People's Hospital of Guangxi Zhuang Autonomous Region

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-31

Primary Completion

2022-12-31

Completion

2024-12-31

Countries

• China

Study Locations