This is a single-center, single-arm, phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.
At present, the standard treatment for patients with operable locally advanced head and neck squamous cell carcinoma (HNSCC) is adjuvant radiotherapy with or without platinum-based synchronous chemotherapy after operation. However, the risk of recurrence, metastasis and death remains high in this population with this intense combination treatment regimen. Both EGFR monoclonal antibody and PD-1 inhibitors have proven the effect in advanced HNSCC. At the same time, cetuximab and PD-1 inhibitors have been reported to have a synergistic effect that may improve patient survival. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Toripalimab by intravenous (IV) infusion every 3 weeks (Q3W), 3 preoperative and 17 consolidated doses. The preoperative starting dose of cetuximab is 400 mg/m\^2 by IV infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m\^2 IV infusion over 60 minutes, from week 2 to 9.
After neoadjuvant therapy, patients would accept surgery within 11-13 weeks.
Adjuvant radiotherapy was given 4 weeks after surgery. Patients with positive intraoperative pathological margins/extra lymph node envelope invasion are treated with an additional cisplatin synchronous chemotherapy.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hebei, China
Pathological Complete Response (pCR) Rate evaluated by investigators
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected tumour and lymph nodes following completion of neoadjuvant therapy.
Time frame: up to 13 weeks after neoadjuvant
2 years Event-free survival (EFS) Rate evaluated by investigators
Event Free Survival (EFS): EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. The 2y-EFS rate is defined as the probability of event-free survival for a patient at a given point in time (2 years).
Time frame: EFS Up to 3 years
Incidence of AEs/SAEs
Overall incidence of adverse events (AEs); incidence of grade 3 and above AEs; incidence of serious adverse events (SAEs).
Time frame: Up to 3 years
Objective Response Rate (ORR) evaluated by investigators
The ORR was defined as proportion of patients whose tumor volume was reduced to 30% and sustained for more than 4 weeks as assessed by RECIST 1.1.
Time frame: Up to 3 years
Major Pathological Response (MPR) Rate evaluated by investigators
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Time frame: up to 13 weeks after neoadjuvant
2 years Disease-free survival (DFS) Rate evaluated by investigators
DFS is defined as the time from postoperation until radiographic disease progression, local or distant recurrence, or death due to any cause. The 2y-DFS rate is defined as the probability of disease-free survival for a patient at a given point in time (2 years).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: DFS Up to 3 years
Organ Retention Rate
Organ retention rate is defined as the proportion of patients whose tumor avoids radical surgery.
Time frame: Up to 3 years