Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
Study NCT ID:
NCT06722495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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:
Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.
Detailed Description:
In recent years, the introduction of PD-1 inhibitors has revolutionized cancer treatment, including head and neck squamous cell carcinoma (HNSCC). Data from The Cancer Genome Atlas (TCGA) shows HNSCC is one of the most immunogenic cancers, linked to immune dysfunction such as impaired immune cell function and antigen presentation defects. Immunotherapy, alone or combined with chemotherapy, has become the standard first-line treatment for recurrent or metastatic HNSCC, as supported by clinical trials like Keynote-040, Keynote-048, and CheckMate 141, which demonstrated improved patient outcomes.
There is also growing interest in neoadjuvant immunotherapy for locally advanced HNSCC. A phase II clinical trial (NCT03174275) showed that neoadjuvant camrelizumab combined with cisplatin and paclitaxel achieved a pathologic complete response (pCR) rate of 37% and a major pathological response (MPR) rate of 74%. Another trial combining PD-1 inhibitor tislelizumab with nab-paclitaxel, platinum, and fluorouracil reported an objective response rate (ORR) of 85.7% and a pCR rate of 42.9%.
In a retrospective analysis of 110 locally advanced oral cavity squamous cell carcinoma (OCSCC) patients treated at our institution, the ORR after two cycles of neoadjuvant immunochemotherapy was 55.4%, with 41% of patients showing stable disease (SD). Further treatment cycles did not improve outcomes for these patients, highlighting the need for alternative treatments for those unresponsive to neoadjuvant therapy.
There is also growing interest in neoadjuvant immunotherapy for locally advanced HNSCC. A phase II clinical trial (NCT03174275) showed that neoadjuvant camrelizumab combined with cisplatin and paclitaxel achieved a pathologic complete response (pCR) rate of 37% and a major pathological response (MPR) rate of 74%. Another trial combining PD-1 inhibitor tislelizumab with nab-paclitaxel, platinum, and fluorouracil reported an objective response rate (ORR) of 85.7% and a pCR rate of 42.9%.
In a retrospective analysis of 110 locally advanced oral cavity squamous cell carcinoma (OCSCC) patients treated at our institution, the ORR after two cycles of neoadjuvant immunochemotherapy was 55.4%, with 41% of patients showing stable disease (SD). Further treatment cycles did not improve outcomes for these patients, highlighting the need for alternative treatments for those unresponsive to neoadjuvant therapy.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: