Head and Neck Squamous Cell CarcinomaPhase 2NCT05351762
Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC
A Phase 2 study testing Nimotuzumab Combined With Neoadjuvant Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Xijing Hospital.
Trial summary
This study is a prospective, open-label, single-arm study. The trial will be divided into 3 phases: screening/baseline, treatment and follow-up. To initially explore the efficacy and safety of nimotuzumab combined with neoadjuvant chemotherapy (TPF regimen) in the treatment of resectable locally advanced head and neck… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab Combined With Neoadjuvant Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Jul 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old, including 18 and 80 years old;
- Resectable stage III to IVa head and neck squamous cell carcinoma (including oropharyngeal carcinoma, laryngeal carcinoma and hypopharyngeal carcinoma) was confirmed by histopathology or cytology by MRI imaging;
- ECOG PS score 0-2;
- Histopathological immunohistochemical test indicated positive EGFR expression
- Histopathological immunohistochemical tests were P16 negative and EBER negative
- Lymph nodes have signs of extraperitoneal invasion (MRI, CT or pathology)
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- At least one measurable lesion according to RECIST 1.1 evaluation criteria;
- Expected survival time ≥6 months;
- Hematologic indexes were basically normal: white blood cell count ≥4×109/L; Neutrophil absolute count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥90 g/L;
- Normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl)> 60 mL/min(Cockcroft-Gault formula was used):
- Female CrCl=(140- age)× body weight (kg)× 0.85 / (72×Scr mg/ dL) Male CrCl=(140- age)× body weight (kg)× 1.00 / (72×Scr mg/dl)
- Normal liver function: serum total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) ≤2.5×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN
- Female patients must have a negative urinary pregnancy test prior to study initiation (not available in patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients)
- Signed written informed consent.
Who cannot join
- Received PD-1 inhibitor, EGFR mab, EGFR-TKI and anti-angiogenic drugs within 4 weeks before enrollment;
- Participating in other interventional clinical trials within 30 days prior to screening;
- History of other malignant tumors (except cured basal cell carcinoma of the skin)
- there are serious and poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, liver failure, renal failure, thyroid disease, mental illness, etc.);
- known to be infected with HIV or active viral hepatitis or tuberculosis;
- Major surgical or planned surgery within 30 days of the first administration of the investigational drug;
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- Allergic to drugs or ingredients used in the program;
- Women who are pregnant (as confirmed by blood or urine HCG testing) or who are lactating, or subjects of childbearing age are unwilling or unable to use effective contraceptive methods (for both male and female subjects) until at least 6 months after the last trial treatment;
- The researcher considers it inappropriate to participate in the study;
- Unwilling to participate in the study or unable to sign the informed consent.
Trial locations and contacts
No sites are listed yet.
Yanyan Jia contact
About this study
Official title: Nimotuzumab Combined With Neoadjuvant Chemotherapy (TPF) in the Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is a prospective, open-label, single-arm study. The trial will be divided into 3 phases: screening/baseline, treatment and follow-up. To initially explore the efficacy and safety of nimotuzumab combined with neoadjuvant chemotherapy (TPF regimen) in the treatment of resectable locally advanced head and neck tumors. Targeted therapy: Nimotuzumab injection 400 mg, once on the 1st day and once on the 21st day, for a total of 2 times. It should be administered by intravenous infusion 1 hour before chemotherapy, and the administration process should last for more than 60 minutes. Chemotherapy (TPF regimen): nab-paclitaxel 175mg/m2, on the 1st day; nedaplatin 100mg/m2, on the 1st day; oral administration of Sigirone on the 1st-14th day, 2/day; a treatment cycle of 21 days, a total of 2 a treatment cycle. After two cycles of chemotherapy, all patients underwent radical surgery according to whether the throat could be preserved and the patient's own wishes. The primary endpoint of the study is the tumor objective response rate (ORR), and the secondary endpoints are the primary tumor pathological complete response (pCR) rate, organ preservation rate, 1-year overall survival (OS) rate, and 1-year disease-free survival (DFS) rate. , quality of life, safety evaluation.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nimotuzumab Combined With Neoadjuvant Chemotherapy
- 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.
Nimotuzumab Combined With Neoadjuvant ChemotherapyDrug
Also called Albumin Paclitaxel, Nedaplatin, Teggio
The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy Receives: Drug: Nimotuzumab Combined With Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 1 year
Secondary outcomes (8)
Primary pathological complete response rate (pCR)
Measured: 1 year
R0 resection rate
Measured: 1 year
Organ retention rate
Measured: 1 year
Overall survival (OS)
Measured: 1 year
Disease free survival (DFS)
Measured: 1 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: 1 year
Incidence of treatment-emergent adverse events
Measured: 1 year
The change of tumor related markers
The correlation of the value of EGFR, SCC-Ag, CEA and therapeutic effect [The changes of serum tumor markers (such as SCC-Ag and CEA were observed before and after treatment. The baseline EGFR levels on the prognosis of patients should also be explored]
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (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 Xijing 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351762
- Sponsor's protocol ID
- BPL-Nim-20210407
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab Combined With Neoadjuvant Chemotherapy (TPF) in the Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05351762
- Acronym / sponsor ID
- BPL-Nim-20210407
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 28 Apr 2022 (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, single-arm study. The trial will be divided into 3 phases: screening/baseline, treatment and follow-up. To initially explore the efficacy and safety of nimotuzumab combined with neoadjuvant chemotherapy (TPF regimen) in the treatment of resectable locally advanced head and neck tumors. Targeted therapy: Nimotuzumab injection 400 mg, once on the 1st day and once on the 21st day, for a total of 2 times. It should be administered by intravenous infusion 1 hour before chemotherapy, and the administration process should last for more than 60 minutes. Chemotherapy (TPF regimen): nab-paclitaxel 175mg/m2, on the 1st day; nedaplatin 100mg/m2, on the 1st day; oral administration of Sigirone on the 1st-14th day, 2/day; a treatment cycle of 21 days, a total of 2 a treatment cycle. After two cycles of chemotherapy, all patients underwent radical surgery according to whether the throat could be preserved and the patient's own wishes. The primary endpoint of the study is the tumor objective response rate (ORR), and the secondary endpoints are the primary tumor pathological complete response (pCR) rate, organ preservation rate, 1-year overall survival (OS) rate, and 1-year disease-free survival (DFS) rate. , quality of life, safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: Nimotuzumab Combined With Neoadjuvant ChemotherapyThe study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18-80 years old, including 18 and 80 years old;
- Resectable stage III to IVa head and neck squamous cell carcinoma (including oropharyngeal carcinoma, laryngeal carcinoma and hypopharyngeal carcinoma) was confirmed by histopathology or cytology by MRI imaging;
- ECOG PS score 0-2;
- Histopathological immunohistochemical test indicated positive EGFR expression
- Histopathological immunohistochemical tests were P16 negative and EBER negative
Key exclusion criteria (10 listed)
- Received PD-1 inhibitor, EGFR mab, EGFR-TKI and anti-angiogenic drugs within 4 weeks before enrollment;
- Participating in other interventional clinical trials within 30 days prior to screening;
- History of other malignant tumors (except cured basal cell carcinoma of the skin)
- there are serious and poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, liver failure, renal failure, thyroid disease, mental illness, etc.);
- known to be infected with HIV 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 |
|---|---|---|
| Nimotuzumab Combined With Neoadjuvant ChemotherapyAlso: Albumin Paclitaxel, Nedaplatin, TeggioThe study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy | Drug | study arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year
8 secondary outcomes
Primary pathological complete response rate (pCR)
Time frame: 1 year
R0 resection rate
Time frame: 1 year
Organ retention rate
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Disease free survival (DFS)
Time frame: 1 year
Quality of life assessed by EORTC QLQ-H&N35
Time frame: 1 year
Incidence of treatment-emergent adverse events
Time frame: 1 year
The change of tumor related markers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Yanyan Jia contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab Combined With Neoadjuvant Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Xijing Hospital.
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 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 5 Jul 2022. 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 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 Li Shi (029- 84771794, shilidoc@163.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) (time frame: 1 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 5 Jul 2022.