Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients.
This is a single-center, Phase II study designed to treat patients with stage III/IVa head and neck squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy involves the administration of benmelstobart combined with anlotinib and chemotherapy for three cycles (21 days per cycle). Surgical resection will be performed within 2 weeks after the completion of neoadjuvant therapy. Tumor tissue samples and blood samples will be collected post-surgery for ctDNA detection. If the post-surgical ctDNA test result is positive, the patient will receive standard adjuvant therapy combined with benmelstobart, along with benmelstobart maintenance therapy. If the result is negative, the patient will receive standard adjuvant therapy alone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Major pathological response,MPR
It is defined as pathological examination shows that the tissue sample has ≤10% viable tumor, i.e. the area of residual viable tumor cell region/surface area of tumor bed ≤10%.
Time frame: up to 9 weeks
Objective response rate (ORR) evaluated by RECIST 1.1
The proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including cases of complete response (CR) and partial response (PR). The tumor's objective response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).
Time frame: up to 9 weeks
Pathological complete remission rate (pCR)
Defined as pathological examination showing 0% viable tumor tissue (0% RVT); calculate the proportion of subjects achieving pathological complete remission (pCR).
Time frame: up to 9 weeks
Disease-free survival rate at 2 years
The proportion of subjects who experienced disease recurrence or died (from any cause) from enrollment to the end of the first year, out of the total number of subjects.
Time frame: from enrollment to the end of the second year
Locoregional recurrence-free survival rate (LRFS) at 2 years
The proportion of subjects who did not experience local or regional lymph node recurrence or death from enrollment to the end of the second year, out of the total number of subjects.
Time frame: from enrollment to the end of the second year
Distant metastasis-free survival rate (DMFS) at 2 years
The proportion of subjects who did not experience distant metastasis from enrollment to the end of the second year, out of the total number of subjects.
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Time frame: from enrollment to the end of the second year
Overall survival rate (OS) at 2 years
The proportion of subjects who died from any cause from enrollment to the end of the second year, out of the total number of subjects.
Time frame: from enrollment to the end of the second year