Head and Neck Squamous Cell CarcinomaPhase 2NCT05024019
Nimotuzumab Combined With Radiotherapy in High-risk Patients With HNSCC Not Suitable for Cisplatin After Surgery
A Phase 2 study testing Nimotuzumab in people with Head and Neck Squamous Cell Carcinoma, run by Eye & ENT Hospital of Fudan University at 6 sites in China.
Trial summary
This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 6 sitesChina
- Study dates
- 21 Aug 2021to 21 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Histology or imaging diagnosed as head and neck (oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer) squamous cell carcinoma; oropharyngeal cancer should be p16 negative (p16 positive defined as p16 ≥ 70%);
- The radical surgery has been completed and patients were suffered from any postoperative risk factors as follows: (1) extranodal extension (ENE); (2) pT3-4; pN2-3; (3) Nerve invasion (PNI) or vascular invasion (LVI); (4) Lymph node metastasis in zone IV or zone V (oral/oropharyngeal cancer); (5) Proximal margin (< 5mm);
- Immunohistochemical detection indicated the EGFR expressions were positive;
- The patients were not suitable for cisplatin chemotherapy: (1) Age>65 years; (2) ECOG PS score>2; (3) Renal dysfunction (creatinine clearance <60ml/min); (4) Severe tinnitus or hearing loss (need hearing aids or hearing tests show 25 decibels threshold or above at two consecutive frequencies); (5) peripheral neuropathy severer than 1 level ; (6) Unable to accept venous hydration, such as cardiac dysfunction or other comorbidities (judged by the investigator); (7) The patient refuses cisplatin chemotherapy;
- Imaging examination did not suggest distant metastasis;
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- Expected survival time ≥ 6 months;
- The following criteria must be met (No transfusion of blood or blood products within 14 days prior to screening): Hb≥90g /L; ANC≥1.0×10*9 /L; PLT≥80×10*9 /L; white blood cell count ≥ 4×10*9 /L; Biochemical examination need to meet the following criteria: serum total bilirubin (TBIL) ≤1.5 ULN; aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 ULN.
- For females of reproductive age, the patients must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be willing to use a reliable method of contraception during the trial. Male subjects should use a reliable method of contraception from the beginning of treatment until 120 days after the last medication;
- The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Who cannot join
- The patients received chemotherapies, PD-1 inhibitors, monoclonal antibody against EGFR, EGFR-TKI, anti-angiogenic drugs within 4 weeks before enrollment;
- The patients participated in other interventional clinical trials within 30 days before screening;
- There was a history of other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ;
- Poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.);
- Known to be infected with HIV virus or active viral hepatitis or tuberculosis;
- There is major surgery within 30 days before taking the trial drug for the first time or there is planned surgery;
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- Allergic to the drugs or their components used in this program;
- Pregnancy (confirmed by blood or urine HCG test) or breastfeeding women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment;
- Patients who are not suitable to participate in this research according to the evaluations of researchers;
- Those who are unwilling to participate in this study or unable to sign the informed consent form.
Trial locations and contacts
6 sites in 1 country.
Yang Guo contact
6 sites in 1 country
China6 sites
The First Affiliated Hospital of Zhejiang University
Hangzhou
Xiaoli Sun
Zhejiang Cancer Hospital
Hangzhou
Xiaozhong Chen
Jiangsu Province Hospital
Nanjing
Yuandong Cao
Ningbo Medical Center Lihuili Hospital
Ningbo
Miaozhen Lu
Huadong Hospital Affiliated to Fudan University
Shanghai
Xiangpeng Zheng
Shanghai General Hospital/First People's Hospital Affiliated with Shanghai Jiao Tong University
Shanghai
Yong Liu
About this study
Official title: A Multicenter Clinical Study of Nimotuzumab Combined With Concurrent Radiotherapy Versus Radiotherapy Alone in High-risk Patients With Head and Neck Squamous Cell Carcinoma Not Suitable for Cisplatin After Surgery
This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group (nimotuzumab combined with concurrent radiotherapy) and control group (radiotherapy alone) by 1∶1 stratified random method.
Read the detailed description
This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group and control group by 1∶1 stratified random method. The study group received nimotuzumab (200mg, weekly, for 6 weeks) combined with concurrent radiotherapy, while the control group received radiotherapy alone. The main endpoint is 2 year disease free survival (DFS) rate.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nimotuzumab
- Keywords
- Nimotuzumab, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
The study group received nimotuzumab (200mg, weekly, for 6 weeks) in combination with radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group received nimotuzumab (200mg, weekly, for 6 weeks) combined with concurrent radiotherapy. Receives: Drug: Nimotuzumab |
| Control group | No intervention | The control group received radiotherapy alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Measured: 2 year
Secondary outcomes (5)
Overall survival (OS)
Measured: 2 year
Local area recurrence free survival (LRRFS)
Measured: 2 year
Distant metastasis free survival (DMFS)
Measured: 2 year
Quality of life assessed by EORTC QLQ-H&N35
Quality of life assessed by EORTC QLQ-H\&N35 [EORTC QLQ-H\&N35 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. A high score represents a higher response level.]
Measured: 2 year
Incidence of treatment-emergent adverse events
Including the incidence of treatment-emergent adverse events[Safety and Tolerability]. Adverse events should be reported and graded according to CTCAE version 5.0.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start21 Aug 2021 (estimated)
- Primary completion21 Aug 2025 (estimated)
- Study completion21 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024019
- Sponsor's protocol ID
- BPL-Nim-SCCHN-6
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Nimotuzumab Combined With Concurrent Radiotherapy Versus Radiotherapy Alone in High-risk Patients With Head and Neck Squamous Cell Carcinoma Not Suitable for Cisplatin After Surgery
- ClinicalTrials.gov ID
- NCT05024019
- Acronym / sponsor ID
- BPL-Nim-SCCHN-6
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Nimotuzumab, HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 21 Aug 2021 (estimated)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 21 Aug 2025 (estimated)
- First posted
- 27 Aug 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 prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group (nimotuzumab combined with concurrent radiotherapy) and control group (radiotherapy alone) by 1∶1 stratified random method.
Detailed description
This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group and control group by 1∶1 stratified random method. The study group received nimotuzumab (200mg, weekly, for 6 weeks) combined with concurrent radiotherapy, while the control group received radiotherapy alone. The main endpoint is 2 year disease free survival (DFS) rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: NimotuzumabThe study group received nimotuzumab (200mg, weekly, for 6 weeks) combined with concurrent radiotherapy. |
| Control group | No intervention | –The control group received radiotherapy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years;
- Histology or imaging diagnosed as head and neck (oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer) squamous cell carcinoma; oropharyngeal cancer should be p16 negative (p16 positive defined as p16 ≥ 70%);
- The radical surgery has been completed and patients were suffered from any postoperative risk factors as follows: (1) extranodal extension (ENE); (2) pT3-4; pN2-3; (3) Nerve invasion (PNI) or vascular invasion (LVI); (4) Lymph node metastasis in zone IV or zone V (oral/oropharyngeal cancer); (5) Proximal margin (< 5mm);
- Immunohistochemical detection indicated the EGFR expressions were positive;
- The patients were not suitable for cisplatin chemotherapy: (1) Age>65 years; (2) ECOG PS score>2; (3) Renal dysfunction (creatinine clearance <60ml/min); (4) Severe tinnitus or hearing loss (need hearing aids or hearing tests show 25 decibels threshold or above at two consecutive frequencies); (5) peripheral neuropathy severer than 1 level ; (6) Unable to accept venous hydration, such as cardiac dysfunction or other comorbidities (judged by the investigator); (7) The patient refuses cisplatin chemotherapy;
Key exclusion criteria (10 listed)
- The patients received chemotherapies, PD-1 inhibitors, monoclonal antibody against EGFR, EGFR-TKI, anti-angiogenic drugs within 4 weeks before enrollment;
- The patients participated in other interventional clinical trials within 30 days before screening;
- There was a history of other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ;
- Poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.);
- Known to be infected with HIV virus or active viral hepatitis or tuberculosis;
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 |
|---|---|---|
| NimotuzumabThe study group received nimotuzumab (200mg, weekly, for 6 weeks) in combination with radiotherapy. | Drug | Study group |
Primary outcome
Disease free survival (DFS)
Time frame: 2 year
5 secondary outcomes
Overall survival (OS)
Time frame: 2 year
Local area recurrence free survival (LRRFS)
Time frame: 2 year
Distant metastasis free survival (DMFS)
Time frame: 2 year
Quality of life assessed by EORTC QLQ-H&N35
Time frame: 2 year
Incidence of treatment-emergent adverse events
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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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.
Yang Guo contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab in people with Head and Neck Squamous Cell Carcinoma, run by Eye & ENT Hospital of Fudan University at 6 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 10 inclusion and 10 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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 Lei Tao (64377134, doctortaolei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 2 year). 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 Aug 2021.