Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554028
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced LaryngealHypopharyngeal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tislelizumab and Induction Chemotherapy Followed by Radiotherapy or Adaptive Surgery for Larynx Preservation in Resectable Locally Advanced Laryngeal or Hypopharyngeal Cancer A Single-Arm Phase II Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-arm single-center phase II study The goal of this clinical trial is to explore the therapeutic value of the treatment model of tislelizumab combined with chemotherapy followed by radiotherapyadaptive surgery on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer
Detailed Description:
Historical studies have shown that induction chemotherapy can provide an opportunity to preserve the larynx in approximately 60-70 of patients with locally advanced laryngealhypopharynx carcinoma Recently phase I-II clinical studies have shown that induction of PD-1 inhibitors has a good pathological response in locally advanced head and neck cancer with or without combined chemotherapy Howeverthe primary lesion and lymph nodes respond asynchronously or even in the opposite way to immune induction therapy The primary lesion is more likely to achieve CRPR while the lymph nodes are more likely to show PRSD or even PD Therefore the surgical or radiotherapy plan should be implemented according to the specific response of the primary lesion and metastatic lymph nodes to induction therapy This study aimed to determine whether the combination of induction chemotherapy with a PD-1 inhibitor Tislelizumab followed by chemoradiotherapy or adaptive surgery can improve the rate of laryngeal preservation in patients with resectable laryngealhypopharynx cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None