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

Glioblastoma Clinical Trial

Official title:

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04157478
• Other study ID #: GXPH-19001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2019
• Source: People's Hospital of Guangxi
• Contact: Heming Lu, MD
• Phone: 86-771-2186-504
• Email: gxheminglu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed and histological proven glioblastoma

• Complete gross resection or subtotal resection

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Adequate bone marrow, liver and renal function

• Written informed consent

Exclusion Criteria:

• Meningeal carcinomatosis or spinal compression

• Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis

• Active, known, or suspected autoimmune disease

• Severe allergy to anlotinib or temozolomide

• Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases

• Uncontrolled mental disorders

• High risk of bleeding

• Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval = 450 ms, women = 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%

• Contraindicated for MRI examination

• Recipient of live vaccine prior to the first dose of anlotinib

• Ready for or previously received organ transplantation

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
China	Nanxishan Hospital of Guangxi Zhuang Autonomous Region	Guilin	Guangxi
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi
China	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Yulin First Hospital	Yulin	Guangxi

Sponsors (7)

Lead Sponsor	Collaborator
People's Hospital of Guangxi	Affiliated Hospital of Guilin University, Cancer Hospital of Guangxi Medical University, First Affiliated Hospital of Guangxi Medical University, Liuzhou People's Hospital, Liuzhou Worker's Hospital, Nanxishan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		3 years
Secondary	Overall survival		3 years
Secondary	Objective response rate		3 years