Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 7:59 PM
Study NCT ID:
NCT07040956
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.
Sponsor:
West China Hospital
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.
Status:
RECRUITING
Status Verified Date:
2025-06
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:
This study aimed to compare the efficacy of neoadjuvant low-dose radiotherapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone in patients with resectable head and neck squamous cell carcinoma.
Detailed Description:
Head and neck squamous cell carcinoma (HNSCC) is a common malignant tumor in the world. Due to its special anatomical location, HNSCC affects patients' appearance and physiological functions. Comprehensive treatments such as surgery, radiotherapy, and chemotherapy are often adopted. More than 60% of patients are diagnosed with locally advanced or metastatic diseases, resulting in a low 5-year survival rate. Locally advanced patients have high recurrence and metastasis rates and a poor prognosis. Neoadjuvant therapy before surgery theoretically can improve the possibility of radical surgery and the organ preservation rate. However, except for nasopharyngeal carcinoma, induction chemotherapy has not brought significant survival benefits to HNSCC patients, and new treatment regimens are urgently needed.
EGFR is overexpressed in 90% of HNSCC patients. The PD-1/PD-L1 signaling pathway is an important mechanism of tumor escape. Anti-PD-1/PD-L1 monoclonal antibodies have shown good efficacy and high safety in the treatment of malignant tumors. The combination of radiotherapy and immunotherapy can induce an anti-tumor immune response. Low-dose radiotherapy has low toxicity and can reprogram the tumor immune microenvironment. Multiple studies have confirmed the safety and feasibility of its combination with immunotherapy.
The previously conducted "Prospective, Single-arm Clinical Study of Low-dose Radiotherapy Plus Tislelizumab Combined with Afatinib for Neoadjuvant Therapy of Resectable Head and Neck Squamous Cell Carcinoma" has demonstrated good safety and efficacy. Based on this, a head-to-head clinical study is planned to compare the efficacy of low-dose radiotherapy combined with targeted therapy and immunotherapy and pure targeted therapy and immunotherapy in patients with resectable HNSCC, explore the clinical benefits of this new treatment measure, and provide new treatment options for HNSCC patients.
EGFR is overexpressed in 90% of HNSCC patients. The PD-1/PD-L1 signaling pathway is an important mechanism of tumor escape. Anti-PD-1/PD-L1 monoclonal antibodies have shown good efficacy and high safety in the treatment of malignant tumors. The combination of radiotherapy and immunotherapy can induce an anti-tumor immune response. Low-dose radiotherapy has low toxicity and can reprogram the tumor immune microenvironment. Multiple studies have confirmed the safety and feasibility of its combination with immunotherapy.
The previously conducted "Prospective, Single-arm Clinical Study of Low-dose Radiotherapy Plus Tislelizumab Combined with Afatinib for Neoadjuvant Therapy of Resectable Head and Neck Squamous Cell Carcinoma" has demonstrated good safety and efficacy. Based on this, a head-to-head clinical study is planned to compare the efficacy of low-dose radiotherapy combined with targeted therapy and immunotherapy and pure targeted therapy and immunotherapy in patients with resectable HNSCC, explore the clinical benefits of this new treatment measure, and provide new treatment options for HNSCC 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?: