Recurrent GlioblastomaPhase 1NCT05201326
Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma
A Phase 1 study testing Bevacizumab，Irinotecan and Re-radiotherapy in people with Recurrent Glioblastoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Bevacizumab，Irinotecan and Re-radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 20 Dec 2024
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The initial diagnosis confirmed by histopathology is World Health Organization WHO grade 4 glioma;
- Surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (Stupp plan) are performed after the initial diagnosis, and recurrence according to the evaluation of neurotumor response (RANO) criteria and/or confirmed by histopathology;
- The expected survival period is ≥3 months;
- Age between 18 and 70 years old;
- KPS score (KPS) ≥ 70, able to take care of most of life, but occasionally need help from others;
- There are measurable lesions on the T1 enhancement sequence of the head MRI;
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- Hematopoietic function: hemoglobin ≥90g/L, platelets ≥90×109/L, white blood cells ≥4×109/L (previous chronic anemia 80-90 g/L or previous low white blood cell level 3-4×109/L Or thrombocytopenia 80-90×109/L, but KPS 70-100 can be considered for admission) (The range of normal values can be fine-tuned due to the different standards of tertiary first-class hospitals);
- Liver function: ALT and AST<1.5 times of high normal (ULN), bilirubin<1.5×ULN;
- Sign the informed consent form;
- Agree to participate in follow-up actions.
Who cannot join
- Other invasive malignant tumors;
- Re-irradiation after receiving recurrence in the past;
- Recurrence more than 3 times or evidence that there is a subdural recurrence disease or a tumor with a maximum diameter of more than 6 cm;
- Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecan in advance;
- Pregnant or nursing mothers;
- Participate in other tests after diagnosis of recurrence;
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- According to CTCAE5.0 standard classification of patients with bleeding above grade 3;
- Symptomatic peripheral vascular disease;
- Known allergy to bevacizumab or irinotecan;
- Patients who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the premise that the prothrombin time international normalized ratio (INR) is ≤1.5, the use of small doses of Huafa for preventive purposes is allowed Farin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);
- Abnormal blood coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolysis or anticoagulation therapy;
- Arterial/venous thrombotic events that occurred within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0 g;
- Long-term unhealed wounds or fractures;
- Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poor arrhythmia control (including men with QTc interval ≥450 ms, women ≥470 ms); according to NYHA standards, III to Grade IV insufficiency or color Doppler ultrasonography of the heart shows that the left ventricular ejection fraction (LVEF) is less than 50%;
- Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), suffering from myocardial ischemia or myocardial infarction, arrhythmia (including QT room Period ≥440 ms) and degree I cardiac insufficiency;
- History of organ transplantation;
- According to the judgment of the researcher, a serious disease that endangers the safety of the patient or affects the completion of the study.
- Poor overall health, even KPS<60;
- Unable to understand the purpose of treatment or unwilling to sign the treatment consent form;
- No capacity for civil conduct or limited capacity for civil conduct.
Trial locations and contacts
1 site in 1 country.
Yunsheng Gao, MD contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiayi Chen, MD, +86-021-64370045 ext. 602400, cjy11756@rjh.com.cn
Yunsheng Gao, MD
About this study
Official title: An Open and Single-arm Prospective Clinical Study of the Safety and Efficacy of Irinotecan and Bevacizumab Combined With Re-radiotherapy in the Treatment of Recurrent Glioblastoma
This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Bevacizumab，Irinotecan and Re-radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab，Irinotecan and Re-radiotherapyDrug
All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy .
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | irinotecan + bevacizumab + Re-radiotherapy Receives: Drug: Bevacizumab，Irinotecan and Re-radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious adverse events (SAE)
Clinical safety
Measured: From baseline to 28 days after the end of treatment
Secondary outcomes (2)
overall survival
the time between the date of enrollment of the patient and death from any cause
Measured: From the beginning of treatment to death or the last follow-up, approximately 24 months
progression free survival
The time between the patient's enrollment and any documented tumor progression or death from any cause.
Measured: From the start of treatment to the date of disease progression or death, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start22 Dec 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIAYI CHEN, Ruijin Hospital
- Investigators
- Jiayi Chen, MD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201326
- Sponsor's protocol ID
- RJHGBMrRT
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 21 Jan 2022
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open and Single-arm Prospective Clinical Study of the Safety and Efficacy of Irinotecan and Bevacizumab Combined With Re-radiotherapy in the Treatment of Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT05201326
- Acronym / sponsor ID
- RJHGBMrRT
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 21 Jan 2022 (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.
This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Bevacizumab，Irinotecan and Re-radiotherapyirinotecan + bevacizumab + Re-radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The initial diagnosis confirmed by histopathology is World Health Organization WHO grade 4 glioma;
- Surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (Stupp plan) are performed after the initial diagnosis, and recurrence according to the evaluation of neurotumor response (RANO) criteria and/or confirmed by histopathology;
- The expected survival period is ≥3 months;
- Age between 18 and 70 years old;
- KPS score (KPS) ≥ 70, able to take care of most of life, but occasionally need help from others;
Key exclusion criteria (21 listed)
- Other invasive malignant tumors;
- Re-irradiation after receiving recurrence in the past;
- Recurrence more than 3 times or evidence that there is a subdural recurrence disease or a tumor with a maximum diameter of more than 6 cm;
- Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecan in advance;
- Pregnant or nursing mothers;
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 |
|---|---|---|
| Bevacizumab，Irinotecan and Re-radiotherapyAll patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy . | Drug | Treatment arm |
Primary outcome
serious adverse events (SAE)
Time frame: From baseline to 28 days after the end of treatment
Clinical safety
2 secondary outcomes
overall survival
Time frame: From the beginning of treatment to death or the last follow-up, approximately 24 months
progression free survival
Time frame: From the start of treatment to the date of disease progression or death, up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- 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.
Yunsheng Gao, MD contact
Jiayi Chen, MD study director
Ruijin 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 study testing Bevacizumab，Irinotecan and Re-radiotherapy in people with Recurrent Glioblastoma, run by Ruijin 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fei xu, MD (18964152276, xf11976@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious adverse events (SAE) (time frame: From baseline to 28 days after the end of treatment). 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 21 Jan 2022.