Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT04157478
- Lead Sponsor
- People's Hospital of Guangxi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 464
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiation therapy, Temozolomide and anlotinib Radiation therapy 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. Radiation therapy and temozolomide Radiation therapy Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Radiation therapy, Temozolomide and anlotinib Anlotinib Hydrochloride 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. Radiation therapy, Temozolomide and anlotinib Temozolomide 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. Radiation therapy and temozolomide Temozolomide Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).
- Primary Outcome Measures
Name Time Method Progression-free survival 3 years
- Secondary Outcome Measures
Name Time Method Objective response rate 3 years Overall survival 3 years
Trial Locations
- Locations (7)
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
Yulin First Hospital
🇨🇳Yulin, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China