Back to resultsNimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nimotuzumab Combined With Neoadjuvant Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study arm
Arm Description
The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Secondary Outcome Measures
Primary pathological complete response rate (pCR)
R0 resection rate
Organ retention rate
Overall survival (OS)
Disease free survival (DFS)
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.]
Incidence of treatment-emergent adverse events
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]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05351762
Brief Title
Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC
Official Title
Nimotuzumab Combined With Neoadjuvant Chemotherapy (TPF) in the Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Arm Description
The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab Combined With Neoadjuvant Chemotherapy
Other Intervention Name(s)
Albumin Paclitaxel, Nedaplatin, Teggio
Intervention Description
The study arm received nimotuzumab (400mg, every three weeks, for 2 weeks) combined with TPF chemotherapy
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Primary pathological complete response rate (pCR)
Time Frame
1 year
Title
R0 resection rate
Time Frame
1 year
Title
Organ retention rate
Time Frame
1 year
Title
Overall survival (OS)
Time Frame
1 year
Title
Disease free survival (DFS)
Time Frame
1 year
Title
Quality of life assessed by EORTC QLQ-H&N35
Description
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.]
Time Frame
1 year
Title
Incidence of treatment-emergent adverse events
Time Frame
1 year
Title
The change of tumor related markers
Description
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]
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Shi
Phone
029- 84771794
Email
shilidoc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Jia
Email
304057101@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC
We'll reach out to this number within 24 hrs