Recurrent GlioblastomaPhase 1NCT05737368
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
A Phase 1 study testing fractionated radiotherapy and cadonilimab in people with Recurrent Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy. 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?
- fractionated radiotherapy and cadonilimab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2023to 28 Feb 2025
- 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
- . Written and signed informed consent.
- . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
- Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
- The maximum diameter of recurrent tumor is less than 6 cm.
- Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
- The interval from the last radiotherapy is more than 6 months.
- KPS (Karnofsky function status score)>60.
Who cannot join
- Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
- Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
- Multiple malignant gliomas.
- Subtentorial glioblastoma or Extracranial metastatic lesions.
- Active autoimmune diseases.
- Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.
- Conditions
- Recurrent Glioblastoma
- Being tested
- fractionated radiotherapy, cadonilimab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated radiotherapyRadiation
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume)
cadonilimabDrug
Cardunizumab (10mg/kg, Q3W, d1)
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive the treatment of fractionated radiotherapy and Cadonilimab | Experimental | fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1) Receives: Radiation: fractionated radiotherapy; Drug: cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: 3 months after treatment
Secondary outcomes (5)
Local control rate (LC)
The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard.
Measured: from date of enrollment to date of first documented local progression. Assessed up to 6 months
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Measured: from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.
Measured: from date of enrollment to the date of progress. Assessed up to 6 months
progression-free survival (PFS)
the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment.
Measured: from date of enrollment to the date of first documented progression. Assessed up to 6 months
survival (OS) rate
Probability of survival for 6 months after treatment
Measured: from date of enrollment to the date of death from any cause. Assessed up to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start28 Feb 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2025 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 11 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, MD/PhD, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737368
- Sponsor's protocol ID
- 2022-0995
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
- ClinicalTrials.gov ID
- NCT05737368
- Acronym / sponsor ID
- 2022-0995
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 21 Feb 2023 (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 evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will receive the treatment of fractionated radiotherapy and Cadonilimab | Experimental | Radiation: fractionated radiotherapy, Drug: cadonilimabfractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- . Written and signed informed consent.
- . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
- Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
- The maximum diameter of recurrent tumor is less than 6 cm.
- Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
Key exclusion criteria (6 listed)
- Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
- Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
- Multiple malignant gliomas.
- Subtentorial glioblastoma or Extracranial metastatic lesions.
- Active autoimmune diseases.
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 |
|---|---|---|
| fractionated radiotherapyfractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume) | Radiation | Patients will receive the treatment of fractionated radiotherapy and Cadonilimab |
| cadonilimabCardunizumab (10mg/kg, Q3W, d1) | Drug | Patients will receive the treatment of fractionated radiotherapy and Cadonilimab |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: 3 months after treatment
5 secondary outcomes
Local control rate (LC)
Time frame: from date of enrollment to date of first documented local progression. Assessed up to 6 months
Objective Response Rate (ORR)
Time frame: from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months
Disease control rate (DCR)
Time frame: from date of enrollment to the date of progress. Assessed up to 6 months
progression-free survival (PFS)
Time frame: from date of enrollment to the date of first documented progression. Assessed up to 6 months
survival (OS) rate
Time frame: from date of enrollment to the date of death from any cause. Assessed up to 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Related trials for Recurrent Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
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.
Qichun Wei, MD/PhD study director
Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fractionated radiotherapy and cadonilimab in people with Recurrent Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 7 inclusion and 6 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Wei Yu, MD (+8657187783521, 11418282@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: 3 months after 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 Feb 2023.