NCT06444009

A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Lei Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

Detailed description

In this study, eligible patients will be randomized in a 1:1:1 ratio to either the ivonescimab combined with chemotherapy treatment group (Cohort 1), or the cadonilimab combined with chemotherapy treatment group (Cohort 2), or the penpulimab combined with chemotherapy treatment group (Cohort 3). Pathological 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	Ivonescimab combined with TP	Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
DRUG	Cadonilimab combined with TP	Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
DRUG	Penpulimab combined with TP	Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2024-06-05
• Last updated: 2024-12-02

Locations

1 site across 1 country: China