Clinical trial NCT04157478: Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma
Anlotinib hydrochloride
Stupp regimen
Temozolomide
Radiation therapy
Tyrosine kinase inhibitor
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Guangxi Medical University
name: Cancer Hospital of Guangxi Medical University
name: Liuzhou Workers Hospital
name: Nanxishan Hospital
name: LiuZhou People's Hospital
name: Affiliated Hospital of Guilin University
First posted: 2019-11-08
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Objective response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guilin
country: China
facility: Nanxishan Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Yulin
country: China
facility: Yulin First Hospital
state: Guangxi
Study officials:
References: