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NOT YET RECRUITING
NCT06537011
PHASE2

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

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-08-01

Completion Date

2028-07-30

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

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.