GliomaPhase 2NCT01567202
Study of DC Vaccination Against Glioblastoma
A Phase 2 study testing Surgery, Chemotherapy and Radiotherapy in people with Glioma and Glioblastoma Multiforme, run by Huashan Hospital at 1 site in China.
Trial summary
This is a Phase II study in a single center to determine the efficacy of autologous dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a vaccination in adults with glioblastoma multiforme (primary or secondary). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Glioblastoma Multiforme, Neoplasms
- What is being tested?
- Surgery, Chemotherapy and Radiotherapy
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to 1 Feb 2021
- Phase
- Phase 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
- Patients with histologically confirmed brain glioblastoma multiforme and molecular subgroups of IDH1 wildtype TERT mutation。
- Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR within 72 hours after surgery.
- Age from 18 through 70 years.
- Karnofsky performance score of ≥ 60%.
- Adequate organ function within 14 days of study registration including the following:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) ≥ 1.0×10^9/L, platelets ≥100×10^9/L; hemoglobin ≥ 9 g/dL. Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) < 3×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance >60 ml/min/1.73 m^2. Electrocardiogram: normal.
- Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol.
- Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure).
- Patients currently received any other investigational agents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
Liangfu Zhou, M.D., 86-21-52889999-7206, lfzhouc@126.com
Chao Tang, M.D.,Ph.D., 15000678905, chaotang@fudan.edu.cn
About this study
Official title: A Triple-blind Randomized Clinical Study of Vaccination With Dendritic Cells Loaded With Glioma Stem-like Cells Associated Antigens Against Brain Glioblastoma Multiform
This is a Phase II study in a single center to determine the efficacy of autologous dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a vaccination in adults with glioblastoma multiforme (primary or secondary).
Read the detailed description
Despite the advances in diagnosis and treatment (surgery +radiation +chemotherapy), median survival for patients with newly diagnosed brain glioblastoma multiform (GBM) is about one year, for recurrent GBM is about 4 months. Recently, immunotherapy has emerged as a novel treatment strategy for glioma with improving patient survival. Usually, processed tumor antigens from the patient's own tumor or a peptide vaccine is capable of producing an anti-glioma response. Our previous experiment revealed that the CD133+ tumor stem-like cells associated antigens could elicit highly intensive immune response against human malignant glioma , and in phase I study, we have confirmed that DC vaccine loaded with glioma stem-like cells associated antigens against malignant glioma in recurrent patients was of safety .
Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each patient. Stem-like cells associated antigens (SAA) will be prepared with glioma stem-like cells that are harvested from patients with GBM and primary cultured and sorted flowcytometrically and then irradiated. Approximately 4 weeks will be required for vaccine production and the first vaccine administration. Each patient will receive an injection of DCs at his/her assigned dose once every week during the first 6 week. The dose of DCs is defined as 8~10×10^6.
Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately, at the present time the majority of clinical trials were in phase I that illustrated the safety. The efficacy of DCs against glioblastoma is still lack of sufficient randomized phase II study. According to our previous phase I study, here we designed this clinical trial in a triple-blind randomized manner to validate the efficacy of DCs vaccination.
Recently，an exploratory randomized phase II clinical trial have been completed （Cancer immunology \&immunotheapy ，2018，1677，1677-1688 ； PubMed ID: 30159779）， 43 GBM patients were randomized after surgery at a 1:1 ratio to receive either DCV (n = 22) or normal saline placebo (n = 21). Overall survival (OS) and progression-free survival (PFS) were analysed. Participants were stratified into different molecular subgroups based on the mutation (MT) status of isocitrate dehydrogenase (IDH1/2) and telomerase reverse transcriptase (TERT). Plasma cytokine levels, tumor-infiltrating lymphocyte numbers and immune co-inhibitory molecules PD-L1 and B7-H4 were also assessed. Multivariate Cox regression analysis revealed that DCV treatment significantly prolonged OS (p = 0.02) after adjusting for IDH1 and TERT promoter MT and B7-H4 expression, primary vs recurrent GBM. Among IDH1wild type (WT) TERTMT patients, DCV treatment significantly prolonged OS (p < 0.01) and PFS (p = 0.03) and increased plasma levels of cytokines CCL22 and IFN-γ compared with placebo. Patients with low B7-H4 expression showed significantly prolonged OS (p = 0.02) after DCV treatment.
In the present study, IDH1WTTERTMT subgroups of GBM patients more responsive to GSC DCV-based specific active-immunotherapy. However，It is noted that IDH1WTTERTMTGBM patients was analysed in a cohort samples which are not randomlized and the present study population is too small to evaluate conclusively demographic criteria for entry and patient recruitment. the results of the present study should be confirmed in a random cohort of IDH1WTTERTMT GBM patients. Accordingly , we made some modifications to the original plan, and are currently recruiting new participants.
- Conditions
- Glioma, Glioblastoma Multiforme, Neoplasms
- Being tested
- Surgery, Chemotherapy, Radiotherapy, DC vaccination, blank placebo
- Keywords
- Brain tumor, Glioma, Glioblastoma, Tumor stem cells, Immunotherapy, Vaccine
- Medical subject headings
- Glioma, Glioblastoma, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Maximum resection of the tumor (≥95%) with the help of conventional or intraoperative MRI neuronavigation. Confirmation will be proceeded by the contrast MRI within 72 hours after surgery.
ChemotherapyDrug
Temozolomide(TMZ), 200mg·m^-2·d ×5 days，28 days every cycle. 6 cycles of TMZ are recommended.
RadiotherapyRadiation
Standard dose, 4500 cGy to tumor with 3-cm margins, 1500 cGy boost to tumor bed.
DC vaccinationBiological
Eight to ten million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes.
blank placeboDrug
Saline that has the same appearance with DC vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Arm DC | Experimental | In this arm, the patients will receive DC vaccination in addition to the standard therapy, including Surgery, Chemotherapy, and Radiotherapy. Receives: Procedure: Surgery; Drug: Chemotherapy; Radiation: Radiotherapy; Biological: DC vaccination |
| Arm Placebo | Placebo comparator | In this arm, the patients will receive blank placebo instead of the DC vaccination in addition to the standard therapy. Receives: Procedure: Surgery; Drug: Chemotherapy; Radiation: Radiotherapy; Drug: blank placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of the treatment using DC Vaccination for Glioblastoma with molecular markers for immunotherapy.
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.Molecular markers are based on the mutation (MT) status of isocitrate dehydrogenase (IDH1/2) and telomerase reverse transcriptase (TERT).
Measured: Every 4 weeks from baseline to 6 months.
Secondary outcomes (2)
Progression free survival
Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.
Measured: Every 4 weeks from baseline to 6 months.
Overall survival
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
Measured: within 2 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Huashan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Liangfu Zhou, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567202
- Sponsor's protocol ID
- DC81001115
- Status last verified
- Sep 2020
- First submitted
- 26 Mar 2012
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hua W, Yao Y, Chu Y, Zhong P, Sheng X, Xiao B, Wu J, Yang B, Mao Y, Zhou L. The CD133+ tumor stem-like cell-associated antigen may elicit highly intense immune responses against human malignant glioma. J Neurooncol. 2011 Nov;105(2):149-57. doi: 10.1007/s11060-011-0572-y. Epub 2011 Apr 11.
PubMed 21479962Hua Wei, Yao Yu, Chu Yiwei, Zhong Ping, Zhang Rong, Zhu Wei, Wu Jingsong, Ma Dexuan, Xu Ming, Mao Ying, Zhou Liangfu. Phase I study of dendritic cells pulsed with tumor stem-like cells associated antigens against malignant glioma in recurrent patients. Chinese Journal of Neurosurgery (Chinese). 2011, 27(1): 90-94.
Xu M, Yao Y, Hua W, Wu Z, Zhong P, Mao Y, Zhou L, Luo F, Chu Y. Mouse glioma immunotherapy mediated by A2B5+ GL261 cell lysate-pulsed dendritic cells. J Neurooncol. 2014 Feb;116(3):497-504. doi: 10.1007/s11060-013-1334-9. Epub 2014 Jan 8.
PubMed 24398615Yao Y, Luo F, Tang C, Chen D, Qin Z, Hua W, Xu M, Zhong P, Yu S, Chen D, Ding X, Zhang Y, Zheng X, Yang J, Qian J, Deng Y, Hoon DSB, Hu J, Chu Y, Zhou L. Molecular subgroups and B7-H4 expression levels predict responses to dendritic cell vaccines in glioblastoma: an exploratory randomized phase II clinical trial. Cancer Immunol Immunother. 2018 Nov;67(11):1777-1788. doi: 10.1007/s00262-018-2232-y. Epub 2018 Aug 22.
PubMed 30159779
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-blind Randomized Clinical Study of Vaccination With Dendritic Cells Loaded With Glioma Stem-like Cells Associated Antigens Against Brain Glioblastoma Multiform
- ClinicalTrials.gov ID
- NCT01567202
- Acronym / sponsor ID
- DC81001115
- Conditions
- Glioma, Glioblastoma Multiforme, Neoplasms
- Keywords
- Brain tumor, Glioma, Glioblastoma, Tumor stem cells, Immunotherapy, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Mar 2012 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- 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 II study in a single center to determine the efficacy of autologous dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a vaccination in adults with glioblastoma multiforme (primary or secondary).
Detailed description
Despite the advances in diagnosis and treatment (surgery +radiation +chemotherapy), median survival for patients with newly diagnosed brain glioblastoma multiform (GBM) is about one year, for recurrent GBM is about 4 months. Recently, immunotherapy has emerged as a novel treatment strategy for glioma with improving patient survival. Usually, processed tumor antigens from the patient's own tumor or a peptide vaccine is capable of producing an anti-glioma response. Our previous experiment revealed that the CD133+ tumor stem-like cells associated antigens could elicit highly intensive immune response against human malignant glioma , and in phase I study, we have confirmed that DC vaccine loaded with glioma stem-like cells associated antigens against malignant glioma in recurrent patients was of safety .
Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each patient. Stem-like cells associated antigens (SAA) will be prepared with glioma stem-like cells that are harvested from patients with GBM and primary cultured and sorted flowcytometrically and then irradiated. Approximately 4 weeks will be required for vaccine production and the first vaccine administration. Each patient will receive an injection of DCs at his/her assigned dose once every week during the first 6 week. The dose of DCs is defined as 8~10×10^6.
Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately, at the present time the majority of clinical trials were in phase I that illustrated the safety. The efficacy of DCs against glioblastoma is still lack of sufficient randomized phase II study. According to our previous phase I study, here we designed this clinical trial in a triple-blind randomized manner to validate the efficacy of DCs vaccination.
Recently，an exploratory randomized phase II clinical trial have been completed （Cancer immunology \&immunotheapy ，2018，1677，1677-1688 ； PubMed ID: 30159779）， 43 GBM patients were randomized after surgery at a 1:1 ratio to receive either DCV (n = 22) or normal saline placebo (n = 21). Overall survival (OS) and progression-free survival (PFS) were analysed. Participants were stratified into different molecular subgroups based on the mutation (MT) status of isocitrate dehydrogenase (IDH1/2) and telomerase reverse transcriptase (TERT). Plasma cytokine levels, tumor-infiltrating lymphocyte numbers and immune co-inhibitory molecules PD-L1 and B7-H4 were also assessed. Multivariate Cox regression analysis revealed that DCV treatment significantly prolonged OS (p = 0.02) after adjusting for IDH1 and TERT promoter MT and B7-H4 expression, primary vs recurrent GBM. Among IDH1wild type (WT) TERTMT patients, DCV treatment significantly prolonged OS (p < 0.01) and PFS (p = 0.03) and increased plasma levels of cytokines CCL22 and IFN-γ compared with placebo. Patients with low B7-H4 expression showed significantly prolonged OS (p = 0.02) after DCV treatment.
In the present study, IDH1WTTERTMT subgroups of GBM patients more responsive to GSC DCV-based specific active-immunotherapy. However，It is noted that IDH1WTTERTMTGBM patients was analysed in a cohort samples which are not randomlized and the present study population is too small to evaluate conclusively demographic criteria for entry and patient recruitment. the results of the present study should be confirmed in a random cohort of IDH1WTTERTMT GBM patients. Accordingly , we made some modifications to the original plan, and are currently recruiting new participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm DC | Experimental | Procedure: Surgery, Drug: Chemotherapy, Radiation: Radiotherapy, Biological: DC vaccinationIn this arm, the patients will receive DC vaccination in addition to the standard therapy, including Surgery, Chemotherapy, and Radiotherapy. |
| Arm Placebo | Placebo comparator | Procedure: Surgery, Drug: Chemotherapy, Radiation: Radiotherapy, Drug: blank placeboIn this arm, the patients will receive blank placebo instead of the DC vaccination in addition to the standard therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically confirmed brain glioblastoma multiforme and molecular subgroups of IDH1 wildtype TERT mutation。
- Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR within 72 hours after surgery.
- Age from 18 through 70 years.
- Karnofsky performance score of ≥ 60%.
- Adequate organ function within 14 days of study registration including the following:
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol.
- Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure).
- Patients currently received any other investigational agents.
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 |
|---|---|---|
| SurgeryMaximum resection of the tumor (≥95%) with the help of conventional or intraoperative MRI neuronavigation. Confirmation will be proceeded by the contrast MRI within 72 hours after surgery. | Procedure or surgery | Arm DC, Arm Placebo |
| ChemotherapyTemozolomide(TMZ), 200mg·m^-2·d ×5 days，28 days every cycle. 6 cycles of TMZ are recommended. | Drug | Arm DC, Arm Placebo |
| RadiotherapyStandard dose, 4500 cGy to tumor with 3-cm margins, 1500 cGy boost to tumor bed. | Radiation | Arm DC, Arm Placebo |
| DC vaccinationEight to ten million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes. | Biological | Arm DC |
| blank placeboSaline that has the same appearance with DC vaccine. | Drug | Arm Placebo |
Primary outcome
Objective response rate (ORR) of the treatment using DC Vaccination for Glioblastoma with molecular markers for immunotherapy.
Time frame: Every 4 weeks from baseline to 6 months.
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.Molecular markers are based on the mutation (MT) status of isocitrate dehydrogenase (IDH1/2) and telomerase reverse transcriptase (TERT).
2 secondary outcomes
Progression free survival
Time frame: Every 4 weeks from baseline to 6 months.
Overall survival
Time frame: within 2 years after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 21479962Hua W, Yao Y, Chu Y, Zhong P, Sheng X, Xiao B, Wu J, Yang B, Mao Y, Zhou L. The CD133+ tumor stem-like cell-associated antigen may elicit highly intense immune responses against human malignant glioma. J Neurooncol. 2011 Nov;105(2):149-57. doi: 10.1007/s11060-011-0572-y. Epub 2011 Apr 11.
- BackgroundHua Wei, Yao Yu, Chu Yiwei, Zhong Ping, Zhang Rong, Zhu Wei, Wu Jingsong, Ma Dexuan, Xu Ming, Mao Ying, Zhou Liangfu. Phase I study of dendritic cells pulsed with tumor stem-like cells associated antigens against malignant glioma in recurrent patients. Chinese Journal of Neurosurgery (Chinese). 2011, 27(1): 90-94.
- Background: PubMed 24398615Xu M, Yao Y, Hua W, Wu Z, Zhong P, Mao Y, Zhou L, Luo F, Chu Y. Mouse glioma immunotherapy mediated by A2B5+ GL261 cell lysate-pulsed dendritic cells. J Neurooncol. 2014 Feb;116(3):497-504. doi: 10.1007/s11060-013-1334-9. Epub 2014 Jan 8.
- Background: PubMed 30159779Yao Y, Luo F, Tang C, Chen D, Qin Z, Hua W, Xu M, Zhong P, Yu S, Chen D, Ding X, Zhang Y, Zheng X, Yang J, Qian J, Deng Y, Hoon DSB, Hu J, Chu Y, Zhou L. Molecular subgroups and B7-H4 expression levels predict responses to dendritic cell vaccines in glioblastoma: an exploratory randomized phase II clinical trial. Cancer Immunol Immunother. 2018 Nov;67(11):1777-1788. doi: 10.1007/s00262-018-2232-y. Epub 2018 Aug 22.
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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.
Liangfu Zhou, M.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery, Chemotherapy and Radiotherapy in people with Glioma and Glioblastoma Multiforme, run by Huashan 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 7 inclusion and 5 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 9 Sep 2020. 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. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangfu Zhou, M.D. (86-21-52889999-7206, lfzhouc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) of the treatment using DC Vaccination for Glioblastoma with molecular markers for immunotherapy. (time frame: Every 4 weeks from baseline to 6 months.). 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 NCT01567202, which also lists 4 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 9 Sep 2020.