Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100497
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-10-20
Brief Title:
Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced LA HNSCC
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
Official Title:
Efficacy and Safety of PD-1 Inhibitor Combined With Chemotherapy in Locally Advanced III-IVB Poorly Differentiated Head and Neck Squamous Cell Carcinoma a Multi Cohort Prospective Phase II Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
Patients with locally advanced stage III to stage IVB poorly differentiated head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma who meet the inclusion criteria will have their blood samples collected tumor tissue samples or patient paraffin tissue and slides for comprehensive genomic sequencing and analysis The study is divided into two groups Arm1 group Patients with stage IVB T4bNxM0 poorly differentiated head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel dose according to the drug instructions for 2 to 3 cycles determined by the researcher based on tumor shrinkage If the imaging achieves complete response CR or partial response PR suitable patients will undergo surgical treatment Patients who are not suitable for surgery or have stable disease SDprogressive disease PD will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment up to a total of 17 cycles Arm2 group Patients with stage III and IVA T3NxM0 T4aNxM0 poorly differentiated head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel dose according to the drug instructions for 2 cycles Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results Patients who do not achieve pathological complete response pCR and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment up to a total of 17 cycles Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy up to a total of 17 cycles After completion of treatment all patients will be followed up every 3 months for 1 year Subsequently patients will be followed up every 6 months for 3 years Thereafter patients will be followed up annually Patient recurrence and survival data will be recorded
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None