Last updated: June 29, 2022
Sponsor: Xijing Hospital
Overall Status: Active - Not Recruiting
Phase
2
Condition
Head And Neck Cancer
Lung Cancer
Carcinoma
Treatment
N/AClinical Study ID
NCT05351762
BPL-Nim-20210407
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18-80 years old, including 18 and 80 years old;
- Resectable stage III to IVa head and neck squamous cell carcinoma (includingoropharyngeal carcinoma, laryngeal carcinoma and hypopharyngeal carcinoma) wasconfirmed 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; Neutrophilabsolute 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)> 60mL/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 orpostmenopausal patients)
- Signed written informed consent.
Exclusion
Exclusion Criteria:
- Received PD-1 inhibitor, EGFR mab, EGFR-TKI and anti-angiogenic drugs within 4 weeksbefore enrollment;
- Participating in other interventional clinical trials within 30 days prior toscreening;
- 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 theinvestigational drug;
- Allergic to drugs or ingredients used in the program;
- Women who are pregnant (as confirmed by blood or urine HCG testing) or who arelactating, or subjects of childbearing age are unwilling or unable to use effectivecontraceptive methods (for both male and female subjects) until at least 6 monthsafter 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.
Study Design
Total Participants: 55
Study Start date:
July 01, 2022
Estimated Completion Date:
July 30, 2024