Status:
COMPLETED
Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma
Lead Sponsor:
West China Hospital
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to evaluate the safety and tolerability of low-dose radiotherapy plus tislelizumab in combination with afatinib neoadjuvant therapy for patients with surgically resectabl...
Detailed Description
Head and neck squamous cell carcinoma (HNSCC) is the most common malignancy of the head and neck. More than 60% of patients with HNSCC have locally advanced or metastatic disease at the time of diagno...
Eligibility Criteria
Inclusion
- Age 18 years or above.
- Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition:
- were newly diagnosed and without distant metastasis;were deemed surgically
- resectable evaluated by a head and neck surgeon;
- were willing to undergo surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ and bone marrow function:
- absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;
- ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL；
- creatinine clearance ≥ 60 ml/min；
- INR≤ 1.5, APTT≤ 1.5×ULN.
- Written informed consent.
Exclusion
- History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
- Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
- Any of prior therapy with:
- anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs；
- antitumor vaccine;
- any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period;
- major surgery or serious trauma within 4 weeks before the first dose;
- toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria.
- With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
- With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
- With hyperthyroidism, or organic thyroid disease.
- With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
- With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
- History of a clear neurological or psychiatric disorder.
- History of drug abuse or alcohol abuse.
- Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
- Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
- Any other factors that are not suitable for inclusion in this study judged by investigators.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06494189
Start Date
July 31 2024
End Date
April 10 2025
Last Update
December 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000