Recurrent Stage IV High Risk NeuroblastomaEarly Phase 1SCMC-S-2020NCT04412408
Study on Sintilimab in Stage IV High Risk Neuroblastoma
A Early Phase 1 study testing Sintilimab in people with Recurrent Stage IV High Risk Neuroblastoma, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Recurrent Stage IV High Risk Neuroblastoma
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Jun 2023
- Phase
- Early 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 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 Months to 12 years
- Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
- Fully recovered from the acute toxic effects of all prior anti-cancer treatment
- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
- At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
- At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
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- Blood counts recovery including White cell count >= 750/mm^3 and Platelet count >= 50,000/mm^3
- Creatinine clearance ≥ 50ml/min
- Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or < 5 in case of liver impairment)
- Life expectancy of at least 4 months
- Negative pregnancy test in women of childbearing potential
- Use of an effective contraceptive method during the whole treatment and
- up to 3 months after the completion of treatment in males and females
- Prior informed consent signed
Who cannot join
- Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
- Patients who are currently receiving another investigational drug are not eligible
- Patients who are currently receiving other anti-cancer agents are not eligible
- Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
- Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
- Patients who have an uncontrolled infection are not eligible.
- Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Song Gu, Doctor, 18930830716, gusong@shsmu.edu.cn
About this study
Official title: Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
- Being tested
- Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab | Experimental | Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window) Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
response
Complete response: (CR): the tumor shrunk more than 50%.
Part of the reaction: (PR): the reduction of tumor body was more than 30%.
No response: (NP): the tumor decreased by less than 30% or increased.
Measured: 2 years after taking the drug
Secondary outcomes (1)
side effect
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 2 years after taking the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Stage IV High Risk NeuroblastomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Xu, MD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412408
- Sponsor's protocol ID
- SCMC-Sintilimab-2020
- Acronym
- SCMC-S-2020
- Status last verified
- Aug 2020
- First submitted
- 27 May 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab
- ClinicalTrials.gov ID
- NCT04412408
- Acronym / sponsor ID
- SCMC-S-2020 / SCMC-Sintilimab-2020
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Jun 2020 (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.
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab | Experimental | Drug: SintilimabSintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years. Dose: 2 mg / kg intravenously for 60 min (± 10 min window) |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 12 Months to 12 years
- Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
- Fully recovered from the acute toxic effects of all prior anti-cancer treatment
- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
- At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
Key exclusion criteria (7 listed)
- Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
- Patients who are currently receiving another investigational drug are not eligible
- Patients who are currently receiving other anti-cancer agents are not eligible
- Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
- Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
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 |
|---|---|---|
| SintilimabSintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years. Dose: 2 mg / kg intravenously for 60 min (± 10 min window) | Drug | Sintilimab |
Primary outcome
response
Time frame: 2 years after taking the drug
Complete response: (CR): the tumor shrunk more than 50%. Part of the reaction: (PR): the reduction of tumor body was more than 30%. No response: (NP): the tumor decreased by less than 30% or increased.
1 secondary outcome
side effect
Time frame: 2 years after taking the drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Related trials for Recurrent Stage IV High Risk Neuroblastoma
Active, not recruitingObservational study
Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
Recurrent Neuroblastoma, Stage 2A Neuroblastoma
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.
Min Xu, MD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sintilimab in people with Recurrent Stage IV High Risk Neuroblastoma, run by Shanghai Children's Medical Center 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: status not confirmed, as of the sponsor's last update on 11 Aug 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Song Gu, MD (18930830716, gusong@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response (time frame: 2 years after taking the drug). 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 11 Aug 2020.