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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

NCT04119674

Glioblastoma

COMPLETED PHASE1/PHASE2

Newly Diagnosed Glioblastoma

NCT04959500

Glioblastoma

ACTIVE_NOT_RECRUITING PHASE2

Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

NCT04725214

MGMT-Unmethylated Glioblastoma

UNKNOWN PHASE2

Hypofractionated Stereotactic Radiotherapy With Anlotinib in Patients With Recurrent High-Grade Gliomas

NCT04197492

Malignant Glioma

ACTIVE_NOT_RECRUITING PHASE2

Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

NCT04004975

Recurrent Glioblastoma

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Anlotinib Hydrochloride

Intervention Type DRUG

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

Intervention Type RADIATION

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

Temozolomide

Intervention Type DRUG

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.

Radiation therapy and temozolomide

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

Group Type ACTIVE_COMPARATOR

Radiation therapy

Intervention Type RADIATION

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

Temozolomide

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Radiation therapy

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

Intervention Type RADIATION

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No