Maintenance Treatment of Diffuse Midline Gliomas in ChildrenNCT07020052

Phase II Exploratory Study of Sequential Triple Therapy (Temozolomide/Anlotinib/Bemarituzumab) in Combination With Concurrent Radiotherapy With Temozolomide and Anlotinib for the Maintenance Treatment of Diffuse Midline Gliomas in Children

An observational study of Maintenance Treatment of Diffuse Midline Gliomas in Children, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 to 18 years
Conditions the study is for: Maintenance Treatment of Diffuse Midline Gliomas in Children
What is being tested?: temozolomide/anlotinib/pembrolizumab
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 33 participants
Where: 1 siteChina
Study dates: 10 Jul 2025to 30 Jul 2030
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 18 years
All sexes
No healthy volunteers
Child, Adult

Study population: Children with diffuse midline glioma diagnosed by pathology.

Who may be able to join

None listed.

Who cannot join

Previously received anti-tumor treatment for diffuse midline glioma;
Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);
Uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention in patients;
Active infections that require treatment;
People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method);
Known history of substance abuse, alcoholism, or drug use;

Show all 10Show fewer

According to the researcher's judgment, there may be other factors that could force the subject to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data;
Patients who the surgeon believes can undergo curative resection;
Active pulmonary tuberculosis;
Serious infections (including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia) that occurred within 4 weeks prior to the start of the study treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

lu wen, doctor contact

027-83262661

wenlu2808@126.com

China1 site

inyinhu Cancer Center, UnionMedical College Affiliated Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei

Other trials in China

About this study

This study is a phase II single center exploratory clinical trial aimed at evaluating the efficacy and safety of temozolomide combined with anlotinib synchronous radiotherapy sequential triple therapy (temozolomide/anlotinib/PD-L1 inhibitor) for the maintenance treatment of diffuse midline gliomas (DMG) in children. The research plan includes 33 children with DMG aged 3-18 years, who have been pathologically diagnosed and have not received systematic treatment. The implementation will be divided into two stages: synchronous radiotherapy and chemotherapy stage (54Gy radiotherapy+oral temozolomide 75mg/m ²+sequential oral anlotinib) and maintenance treatment stage (increasing temozolomide dose+continuous use of anlotinib+intravenous injection of PD-L1 inhibitor according to body weight). Through multi mechanism synergy (radiotherapy sensitization, anti angiogenesis, and immune activation), the limitations of traditional treatment will be overcome. The primary endpoint is progression free survival (PFS), while secondary endpoints include objective response rate (ORR), 2-year overall survival rate (2y OS), quality of life, and safety (CTCAE 4.0 criteria). The innovation of the research lies in the first proposal of a "synchronous maintenance" staged mode, targeting the molecular characteristics of DMG (H3K27M mutation), combined with previous evidence at home and abroad (such as the median PFS of 10.2 months for anlotinib combined with synchronous radiotherapy), aiming to provide a new comprehensive treatment plan for this highly invasive tumor.

Conditions: Maintenance Treatment of Diffuse Midline Gliomas in Children
Being tested: temozolomide/anlotinib/pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

temozolomide/anlotinib/pembrolizumabDrug
Starting from 30 days after radiotherapy, adjuvant temozolomide was orally administered at a dose of 150mg/m2. The dosage of temozolomide was adjusted to 200mg/m2 starting from the second cycle, with continuous use for 5 days per week and a 23 day hiatus. Oral administration for a total of 6 cycles.
The start time of oral administration of anlotinib after radiotherapy follows the cycle of radiotherapy, with continuous oral administration for 2 weeks and cessation for 1 week. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months.
Begin treatment with bemarituzumab 24 hours after radiotherapy, with a body weight of>=45kg, intravenous injection of 200mg, once every 3 weeks. Weight<45kg, 100mg intravenous injection, once every 3 weeks. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months.

Study groups in NCT07020052
Study group	Role	What they receive
triple therapy		Starting from 30 days after radiotherapy, adjuvant temozolomide was orally administered at a dose of 150mg/m2. The dosage of temozolomide was adjusted to 200mg/m2 starting from the second cycle, with continuous use for 5 days per week and a 23 day hiatus. Oral administration for a total of 6 cycles. The start time of oral administration of anlotinib after radiotherapy follows the cycle of radiotherapy, with continuous oral administration for 2 weeks and cessation for 1 week. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months. Begin treatment with bemarituzumab 24 hours after radiotherapy, with a body weight of>=45kg, intravenous injection of 200mg, once every 3 weeks. Weight<45kg, 100mg intravenous injection, once every 3 weeks. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months. Receives: Drug: temozolomide/anlotinib/pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

progression-free survival
The survival time of no progression in tumor after therapy
Measured: 5years

Secondary outcomes (2)

ORR
objective relief rate
Measured: 3 months
2-year OS
overall survival rate in 2years
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202530 Jul 2030

First posted13 Jun 2025
Study start10 Jul 2025 (estimated)
Primary completion10 Apr 2030 (estimated)
Study completion30 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Maintenance Treatment of Diffuse Midline Gliomas in ChildrenStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 33 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07020052
Sponsor's protocol ID: DMGtriple2025
Status last verified: Jun 2025
First submitted: 5 Jun 2025
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Cohen EE, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, Brockstein BE, Agulnik MB, Mittal BB, Yunus F, Samant S, Raez LE, Mehra R, Kumar P, Ondrey F, Marchand P, Braegas B, Seiwert TY, Villaflor VM, Haraf DJ, Vokes EE. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. J Clin Oncol. 2014 Sep 1;32(25):2735-43. doi: 10.1200/JCO.2013.54.6309. Epub 2014 Jul 21.
PubMed 25049329
Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
PubMed 29658848
Ogino T, Shigyo H, Ishii H, Katayama A, Miyokawa N, Harabuchi Y, Ferrone S. HLA class I antigen down-regulation in primary laryngeal squamous cell carcinoma lesions as a poor prognostic marker. Cancer Res. 2006 Sep 15;66(18):9281-9. doi: 10.1158/0008-5472.CAN-06-0488.
PubMed 16982773
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
PubMed 30280658
Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
PubMed 29658856
Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
PubMed 17960012
Eason T, Mihalko W, Toy PC. Robotic-Assisted Total Knee Arthroplasty is Safe in the Ambulatory Surgery Center Setting. Orthop Clin North Am. 2023 Apr;54(2):153-159. doi: 10.1016/j.ocl.2022.11.001.
PubMed 36894288
Wolff HA, Overbeck T, Roedel RM, Hermann RM, Herrmann MK, Kertesz T, Vorwerk H, Hille A, Matthias C, Hess CF, Christiansen H. Toxicity of daily low dose cisplatin in radiochemotherapy for locally advanced head and neck cancer. J Cancer Res Clin Oncol. 2009 Jul;135(7):961-7. doi: 10.1007/s00432-008-0532-x. Epub 2008 Dec 24.
PubMed 19107519
Yu Y, Yang G, Huang H, Fu Z, Cao Z, Zheng L, You L, Zhang T. Preclinical models of pancreatic ductal adenocarcinoma: challenges and opportunities in the era of precision medicine. J Exp Clin Cancer Res. 2021 Jan 5;40(1):8. doi: 10.1186/s13046-020-01787-5.
PubMed 33402215

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Exploratory Study of Sequential Triple Therapy (Temozolomide/Anlotinib/Bemarituzumab) in Combination With Concurrent Radiotherapy With Temozolomide and Anlotinib for the Maintenance Treatment of Diffuse Midline Gliomas in Children
ClinicalTrials.gov ID: NCT07020052
Acronym / sponsor ID: DMGtriple2025
Conditions: Maintenance Treatment of Diffuse Midline Gliomas in Children
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 33 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 10 Jul 2025 (estimated)
Primary completion: 10 Apr 2030 (estimated)
Study completion: 30 Jul 2030 (estimated)
First posted: 13 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
triple therapy	–	Drug: temozolomide/anlotinib/pembrolizumabStarting from 30 days after radiotherapy, adjuvant temozolomide was orally administered at a dose of 150mg/m2. The dosage of temozolomide was adjusted to 200mg/m2 starting from the second cycle, with continuous use for 5 days per week and a 23 day hiatus. Oral administration for a total of 6 cycles. The start time of oral administration of anlotinib after radiotherapy follows the cycle of radiotherapy, with continuous oral administration for 2 weeks and cessation for 1 week. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months. Begin treatment with bemarituzumab 24 hours after radiotherapy, with a body weight of>=45kg, intravenous injection of 200mg, once every 3 weeks. Weight<45kg, 100mg intravenous injection, once every 3 weeks. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months.

Who may qualify

Ages: 3 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Children with diffuse midline glioma diagnosed by pathology.

Key inclusion criteria (0 listed)

Key exclusion criteria (10 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
temozolomide/anlotinib/pembrolizumabStarting from 30 days after radiotherapy, adjuvant temozolomide was orally administered at a dose of 150mg/m2. The dosage of temozolomide was adjusted to 200mg/m2 starting from the second cycle, with continuous use for 5 days per week and a 23 day hiatus. Oral administration for a total of 6 cycles. The start time of oral administration of anlotinib after radiotherapy follows the cycle of radiotherapy, with continuous oral administration for 2 weeks and cessation for 1 week. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months. Begin treatment with bemarituzumab 24 hours after radiotherapy, with a body weight of>=45kg, intravenous injection of 200mg, once every 3 weeks. Weight<45kg, 100mg intravenous injection, once every 3 weeks. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months.	Drug	triple therapy

Primary outcome

progression-free survival
Time frame: 5years
The survival time of no progression in tumor after therapy

2 secondary outcomes

ORR
Time frame: 3 months
2-year OS
Time frame: 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Results publication: PubMed 25049329Cohen EE, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, Brockstein BE, Agulnik MB, Mittal BB, Yunus F, Samant S, Raez LE, Mehra R, Kumar P, Ondrey F, Marchand P, Braegas B, Seiwert TY, Villaflor VM, Haraf DJ, Vokes EE. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. J Clin Oncol. 2014 Sep 1;32(25):2735-43. doi: 10.1200/JCO.2013.54.6309. Epub 2014 Jul 21.
Results publication: PubMed 29658848Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
Results publication: PubMed 16982773Ogino T, Shigyo H, Ishii H, Katayama A, Miyokawa N, Harabuchi Y, Ferrone S. HLA class I antigen down-regulation in primary laryngeal squamous cell carcinoma lesions as a poor prognostic marker. Cancer Res. 2006 Sep 15;66(18):9281-9. doi: 10.1158/0008-5472.CAN-06-0488.
Results publication: PubMed 30280658Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
Results publication: PubMed 29658856Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
Results publication: PubMed 17960012Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
Results publication: PubMed 36894288Eason T, Mihalko W, Toy PC. Robotic-Assisted Total Knee Arthroplasty is Safe in the Ambulatory Surgery Center Setting. Orthop Clin North Am. 2023 Apr;54(2):153-159. doi: 10.1016/j.ocl.2022.11.001.
Results publication: PubMed 19107519Wolff HA, Overbeck T, Roedel RM, Hermann RM, Herrmann MK, Kertesz T, Vorwerk H, Hille A, Matthias C, Hess CF, Christiansen H. Toxicity of daily low dose cisplatin in radiochemotherapy for locally advanced head and neck cancer. J Cancer Res Clin Oncol. 2009 Jul;135(7):961-7. doi: 10.1007/s00432-008-0532-x. Epub 2008 Dec 24.
Results publication: PubMed 33402215Yu Y, Yang G, Huang H, Fu Z, Cao Z, Zheng L, You L, Zhang T. Preclinical models of pancreatic ductal adenocarcinoma: challenges and opportunities in the era of precision medicine. J Exp Clin Cancer Res. 2021 Jan 5;40(1):8. doi: 10.1186/s13046-020-01787-5.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

lu wen, doctor contact

027-83262661

wenlu2808@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact lu wen, doctor (027-83262661, wenlu2808@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 5years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07020052, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.