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

People's Hospital of Guangxi

Status and phase: Not yet enrolling; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Temozolomide; Radiation: Radiation therapy; Drug: Anlotinib Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04157478

GXPH-19001

Details and patient eligibility

About

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.

Enrollment: 464 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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464 participants in 2 patient groups

Radiation therapy, Temozolomide and anlotinib

Experimental group

Description:

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). 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.

Treatment:

Drug: Anlotinib Hydrochloride

Radiation: Radiation therapy

Drug: Temozolomide

Radiation therapy and temozolomide

Active Comparator group

Description:

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).

Treatment:

Radiation: Radiation therapy

Drug: Temozolomide