Locally Advanced Head and Neck Squamous Cell CarcinomaRedbull-1NCT04949503
A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN
An observational study of Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Biotech Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- nimotuzumab
- How many people
- 1,931 participants
- Where
- 5 sitesChina
- Study dates
- 8 Oct 2021to 30 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were more than 18 years old, and were proved to be LASCCHN were included in this study. Patients in the control group receive chemoradiotherapy, while patients in the study group received nimotuzumab on the basis of chemoradiotherapy.
Who may be able to join
- Age ≥18 years old, no gender limitation;
- Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
- Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
- Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.
Who cannot join
- Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
- Lack of critical evaluation information.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, 510000
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shannxi, 710061
About this study
Official title: A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .
Read the detailed description
This study is a retrospective real-world study. The diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. In this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018. Patients included in the study will be followed up for survival. The main endpoint is 3-year overall survival (OS) rate; the secondary endpoint are 3-year progression-free survival (PFS) rate, 3-year Local-regional control (LRC) rate, objective response rate (ORR), disease control rate (DCR) and safety.
- Being tested
- nimotuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
Also called chemoradiotherapy
Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients of study group were all treated with chemoradiotherapy plus nimotuzumab. Receives: Drug: nimotuzumab | |
| control group | Patients of control group were only treated with chemoradiotherapy, and were collected at least 3 times as many patients as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival (OS) rate
3-year overall survival (OS) rate
Measured: Up to 3 years
Secondary outcomes (5)
3-year progression-free survival (PFS) rate
3-year progression-free survival (PFS) rate
Measured: Up to 3 years
3-year Local-regional control (LRC) rate
3-year Local-regional control (LRC) rate
Measured: Up to 3 years
objective response rate (ORR)
objective response rate (ORR)=CR+PR
Measured: Up to 12 months
disease control rate (DCR)
disease control rate (DCR)
Measured: Up to 12 months
Safety as measured by number and grade of adverse events
Classification, frequency, and severity of drug-related adverse events
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Oct 2021
- Primary completion15 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,931 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinyi Lang, Study chair, Sichuan Cancer Hospital and Research InstituteChenping Zhang, Study chair, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedcineJunlin Yi, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949503
- Sponsor's protocol ID
- BPL-Nimo-SCCHN-RWS-1
- Acronym
- Redbull-1
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04949503
- Acronym / sponsor ID
- Redbull-1 / BPL-Nimo-SCCHN-RWS-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,931 participants (actual)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Jul 2021 (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 study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .
Detailed description
This study is a retrospective real-world study. The diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. In this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018. Patients included in the study will be followed up for survival. The main endpoint is 3-year overall survival (OS) rate; the secondary endpoint are 3-year progression-free survival (PFS) rate, 3-year Local-regional control (LRC) rate, objective response rate (ORR), disease control rate (DCR) and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Drug: nimotuzumabPatients of study group were all treated with chemoradiotherapy plus nimotuzumab. |
| control group | – | –Patients of control group were only treated with chemoradiotherapy, and were collected at least 3 times as many patients as the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were more than 18 years old, and were proved to be LASCCHN were included in this study. Patients in the control group receive chemoradiotherapy, while patients in the study group received nimotuzumab on the basis of chemoradiotherapy.
Key inclusion criteria (4 listed)
- Age ≥18 years old, no gender limitation;
- Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
- Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
- Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.
Key exclusion criteria (3 listed)
- Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
- Lack of critical evaluation information.
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 |
|---|---|---|
| nimotuzumabAlso: chemoradiotherapyPatients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group). | Drug | study group |
Primary outcome
3-year overall survival (OS) rate
Time frame: Up to 3 years
3-year overall survival (OS) rate
5 secondary outcomes
3-year progression-free survival (PFS) rate
Time frame: Up to 3 years
3-year Local-regional control (LRC) rate
Time frame: Up to 3 years
objective response rate (ORR)
Time frame: Up to 12 months
disease control rate (DCR)
Time frame: Up to 12 months
Safety as measured by number and grade of adverse events
Time frame: Up to 3 years
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 27 Jul 2023.
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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.
Jinyi Lang study chair
Sichuan Cancer Hospital and Research Institute
Chenping Zhang study chair
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medcine
Junlin Yi study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Biotech Pharmaceutical Co., Ltd. at 5 sites 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 4 inclusion and 3 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
3-year overall survival (OS) rate (time frame: Up to 3 years). 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 27 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.