NCT06199271

Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma

Neoadjuvant Adebrelimab Plus Dalpiciclib in HPV-negative Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhongzheng Xiang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive Adebrelimab plus Dalpiciclib as neoadjuvant regimen before surgery. This proposed study will evaluate the efficacy and safety of preoperative administration of Adebrelimab plus Dalpiciclib in HNSCC who are eligible for resection.

Detailed description

In this study, eligible patients will be enrolled into study arm to accept study treatment. Pathological response rate and objective response rate will be the primary outcome measures. Adverse events will also be recorded.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab and dalpiciclib	Before surgery, the eligible patients received 3 cycles of adebrelimab (1200 mg intravenously every 3 weeks, Day 1, 22 and 43) and 2 cycles of dalpiciclib (150 mg, po, every 4 weeks, day 1-21 and 29-49). Administration dose adjustments were permitted according to the haematological or non-haematological toxicity.

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-01-10
• Last updated: 2024-01-22