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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04157478
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

People's Hospital of Guangxi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOtherOther
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Radiation therapy, Temozolomide and anlotinib

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.

Active Comparator: Radiation therapy and temozolomide

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guilin, Guangxi, China

Status

Address

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Guilin, Guangxi, 541002

Liuzhou Worker's Hospital, Liuzhou, Guangxi, China

Status

Address

Liuzhou Worker's Hospital

Liuzhou, Guangxi, 545005

Liuzhou People's Hospital, Liuzhou, Guangxi, China

Status

Address

Liuzhou People's Hospital

Liuzhou, Guangxi, 545006

Nanning, Guangxi, China

Status

Address

Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021

Nanning, Guangxi, China

Status

Address

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021

Nanning, Guangxi, China

Status

Address

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021

Site Contact

Heming Lu, MD

gxheminglu@sina.com

+86-771-218-6503

Yulin First Hospital, Yulin, Guangxi, China

Status

Address

Yulin First Hospital

Yulin, Guangxi, 537000

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