NCT06537011

AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

An Exploratory Phase II Study of Neoadjuvant Treatment With AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.

Detailed description

This exploratory phase II study is designed to enroll 36 patients with operable locally advanced head and neck squamous cell carcinoma(defined according to 8th teh edition of AJCC Guideline). The patients are given 3cycles of AK112(20mg/Kg per cycle) combined with AP regimen(platinum based chemotherapy), with a 3-week interval between each cycle (d1,d22,d43). After 3 cycles' therapy, if the volume of primary tumor decreases by over 50%，the range of resection operation will be conducted by the actual range of tumor, or else the surgery will be conducted by the original range of the tumor. The adjuvant radiation therapy would be conducted in 4-6 weeks after the surgery, while the adjuvant therapy of AK112 would be given in 21days after the surgery for 14 cycles. The process will continue until disease progression or uncontrolled toxicity. The primary endpoint is pCR(pathological complete response) and 2y-EFS; the secondary endpoint is MPR(Main pathological response)、ORR(objective response rate)、2y-OS(overall survival)、organ retention rate and safety assessment.

Conditions

• Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	AK112	1. The patients are given AK112 combined with AP regimen every 3 weeks for 3 cycles before operation. 2. After the neoadjuvant therapy ,the patients will be assessed and be commanded surgery. 3.4-6 weeks after the surgery, the patients will be given chemoradiotherapy or radiotherapy alone decided on the conditon after surgery. 4.The participants will receive AK112 for 14 cycles after surgery.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-07-15
• Completion: 2028-07-30
• First posted: 2024-08-05
• Last updated: 2024-08-06