GlioblastomaPhase 1/2NCT04119674
Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
A Phase 1/2 study testing Drug is Anlotinib., Drug is Temozolomide Capsule. and Radiotherapy was initiated 4 to 6 weeks postoperatively. in people with Glioblastoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Drug is Anlotinib., Drug is Temozolomide Capsule. and Radiotherapy was initiated 4 to 6 weeks postoperatively.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2019to 23 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
- 2 ~ 6 weeks after operation; the surgical incision healed well;
- Presence of lesions evaluable according to Rano criteria;
- Aged 18-70 years;
- Karnofsky performance status (KPS) ≥ 60;
- The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
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- No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
- Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
- Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
- Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
- Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
- Patient is sufficiently compliant with study and follow-up procedures;
- Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.
Who cannot join
- Secondary glioblastoma;
- Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
- Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- Pregnant or lactating women;
- Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
- Evidence of hereditary bleeding constitution or coagulation disorders;
- Patients requiring anticoagulant therapy due to other diseases;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
- Conditions
- Glioblastoma
- Being tested
- Drug is Anlotinib., Drug is Temozolomide Capsule., Radiotherapy was initiated 4 to 6 weeks postoperatively.
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug is Anlotinib.Drug
Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .
Drug is Temozolomide Capsule.Drug
Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .
Radiotherapy was initiated 4 to 6 weeks postoperatively.Radiation
Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy. Receives: Drug: Drug is Anlotinib.; Drug: Drug is Temozolomide Capsule.; Radiation: Radiotherapy was initiated 4 to 6 weeks postoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival
Measured: from enrollment to progression or death (for any reason),assessed up to 18months
Secondary outcomes (4)
OS
Overall Survival
Measured: from enrollment to death (for any reason).assessed up to 24 months
adverse event
Adverse events are described in terms of CTC AE 5.0
Measured: from enrollment to death (for any reason).assessed up to 24 months
Health-related quality of life
Health-related quality of life are measured by the EORTC-QL30/BN20.
Measured: from enrollment to death (for any reason).assessed up to 24 months
Neurocognitive function
Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).
Measured: from enrollment to death (for any reason).assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start19 Mar 2019
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen yuanyuan, Zhejiang Cancer Hospital
- Investigators
- Chen Ming, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119674
- Sponsor's protocol ID
- GBM-AS
- Status last verified
- Sep 2023
- First submitted
- 6 Oct 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT04119674
- Acronym / sponsor ID
- GBM-AS
- Conditions
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 8 Oct 2019 (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.
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: Drug is Anlotinib., Drug: Drug is Temozolomide Capsule., Radiation: Radiotherapy was initiated 4 to 6 weeks postoperatively.single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
- 2 ~ 6 weeks after operation; the surgical incision healed well;
- Presence of lesions evaluable according to Rano criteria;
- Aged 18-70 years;
- Karnofsky performance status (KPS) ≥ 60;
Key exclusion criteria (7 listed)
- Secondary glioblastoma;
- Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
- Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- Pregnant or lactating women;
- Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
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 |
|---|---|---|
| Drug is Anlotinib.Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance . | Drug | single-arm |
| Drug is Temozolomide Capsule.Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles . | Drug | single-arm |
| Radiotherapy was initiated 4 to 6 weeks postoperatively.Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy. | Radiation | single-arm |
Primary outcome
PFS
Time frame: from enrollment to progression or death (for any reason),assessed up to 18months
Progression-Free Survival
4 secondary outcomes
OS
Time frame: from enrollment to death (for any reason).assessed up to 24 months
adverse event
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Health-related quality of life
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Neurocognitive function
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chen Ming principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Drug is Anlotinib., Drug is Temozolomide Capsule. and Radiotherapy was initiated 4 to 6 weeks postoperatively. in people with Glioblastoma, run by Zhejiang Cancer Hospital at 1 site in China.
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 14 inclusion and 7 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: finished, as of the sponsor's last update on 22 Sep 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from enrollment to progression or death (for any reason),assessed up to 18months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.