Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 1\. Patients with head and neck squamous cell carcinoma diagnosed by histology or cytology;

• 2\. Have not received systematic treatment for head and neck squamous cell carcinoma in the past;

• 3\. According to the AJCC TNM staging system, it is divided into stages III-IVB;

• 4\. ECOG score: 0-1 point;

• 5\. Expected survival period ≥ 12 weeks;

• 6\. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);

• 7\. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period, at least 6 months after the last use of adebelimab, and at least 6 months after the last use of chemotherapy;

• 8\. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Locations
Other Locations
China
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Contact Information
Primary
Xiuping Ding, Dr.
drdxp85@126.com
+86 18654539599
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 69
Treatments
Experimental: Group 1
TP regimen Adbelimab Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.
Sponsors
Leads: Xiuping Ding

This content was sourced from clinicaltrials.gov