Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494189
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
A Prospective Single-arm Clinical Study of Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 resectable squamous carcinoma of the head and neck
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 diagnosis with a 5-year overall survival rate of less than 60 The clinical outcomes of those patients still need to be improved
Neoadjuvant therapy theoretically can reduce tumor volume increase organ retention rate and reduce distant metastasis rate However in addition to nasopharyngeal carcinoma results from several phase III clinical trials have not proved a significant survival benefit of neoadjuvant chemotherapy for patients with resectable HNSCC It is urgent to explore new neoadjuvant treatment options to improve the prognosis of patients with HNSCC
Immunotherapy such as PD-1PD-L1 inhibitors have shown excellent efficiency in the treatment of malignancies Anti-PD-1 therapy is approved as the first-line treatment of recurrentmetastatic HNSCC Neoadjuvant immunotherapy for the treatment of locally advanced and resectable HNSCC has been demonstrated to be feasible in some trials
Afatinib as an irreversible ErbB tyrosine kinase inhibitor TKI has been used as the second-line treatment for recurrent andor metastatic HNSCC However there is a lack of high-level evidence-based medical evidence for the use of afatinib in preoperative therapy for HNSCC A previous study published in 2018 confirmed that afatinib can be administered safely before surgery
Radiotherapy is the standard or adjuvant treatment for most patients with head and neck cancer In HNSCC combining radiotherapy with immunotherapy has been shown to induce effective anti-tumor immune responses The mechanism may be that in addition to direct cytotoxic effects on cancer cells radiotherapy remodels the tumor microenvironment and affects the number and composition of tumor-infiltrating immune cells thereby altering the response to immune checkpoint inhibitor therapy
However conventional radiation therapy is often associated with adverse effects such as dry mouth dysphagia oral mucositis and pain which will lead to a reduction in the quality of life of the patient and severe adverse effects can even lead to interruption of treatment Low-dose radiotherapy LDRT is usually defined as radiotherapy with 2 Gray Gy per fraction and a total dose of up to 10 Gy and is considered to be a non-ablative treatmentLDRT has less impact on the patient compared to conventional radiation therapy and its low toxicity makes it suitable for tumor lesions that are not amenable to stereotactic radiation therapyIn addition to its low radiotherapy toxicity LDRT has been shown to cause tumor regression by reprogramming the tumor immune microenvironment
In conclusion the researchers designed this study to investigate the efficacy and safety of low-dose radiotherapy plus the anti-PD1 immunotherapy teslizumab in combination with an epidermal growth factor receptor-TKI afatinib as a neoadjuvant treatment option for patients with resectable HNSCC with the aim of providing a new therapeutic option for these patients
Neoadjuvant therapy theoretically can reduce tumor volume increase organ retention rate and reduce distant metastasis rate However in addition to nasopharyngeal carcinoma results from several phase III clinical trials have not proved a significant survival benefit of neoadjuvant chemotherapy for patients with resectable HNSCC It is urgent to explore new neoadjuvant treatment options to improve the prognosis of patients with HNSCC
Immunotherapy such as PD-1PD-L1 inhibitors have shown excellent efficiency in the treatment of malignancies Anti-PD-1 therapy is approved as the first-line treatment of recurrentmetastatic HNSCC Neoadjuvant immunotherapy for the treatment of locally advanced and resectable HNSCC has been demonstrated to be feasible in some trials
Afatinib as an irreversible ErbB tyrosine kinase inhibitor TKI has been used as the second-line treatment for recurrent andor metastatic HNSCC However there is a lack of high-level evidence-based medical evidence for the use of afatinib in preoperative therapy for HNSCC A previous study published in 2018 confirmed that afatinib can be administered safely before surgery
Radiotherapy is the standard or adjuvant treatment for most patients with head and neck cancer In HNSCC combining radiotherapy with immunotherapy has been shown to induce effective anti-tumor immune responses The mechanism may be that in addition to direct cytotoxic effects on cancer cells radiotherapy remodels the tumor microenvironment and affects the number and composition of tumor-infiltrating immune cells thereby altering the response to immune checkpoint inhibitor therapy
However conventional radiation therapy is often associated with adverse effects such as dry mouth dysphagia oral mucositis and pain which will lead to a reduction in the quality of life of the patient and severe adverse effects can even lead to interruption of treatment Low-dose radiotherapy LDRT is usually defined as radiotherapy with 2 Gray Gy per fraction and a total dose of up to 10 Gy and is considered to be a non-ablative treatmentLDRT has less impact on the patient compared to conventional radiation therapy and its low toxicity makes it suitable for tumor lesions that are not amenable to stereotactic radiation therapyIn addition to its low radiotherapy toxicity LDRT has been shown to cause tumor regression by reprogramming the tumor immune microenvironment
In conclusion the researchers designed this study to investigate the efficacy and safety of low-dose radiotherapy plus the anti-PD1 immunotherapy teslizumab in combination with an epidermal growth factor receptor-TKI afatinib as a neoadjuvant treatment option for patients with resectable HNSCC with the aim of providing a new therapeutic option for these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None